Industry: Medical Device

For all Expertise Items that belong to the Medical Device Industry

Quality Risk Management Plan

A well-written and well-implemented quality risk management plan is an integral element of an effective quality system. During the development of your total quality strategy, the bottom line is that things can and will go wrong. Your QA management team and QMS system need to be designed with data quality management in mind. Your team should include employees from multiple functions who understand both risk and compliance. 

 

Quality Risk Management

 

regulatory complianceThe purpose of quality risk management is to help ensure continued compliance with regulatory requirements, such as good manufacturing practices. This is critical for risks analysis when events occur during manufacturing that can impact patient safety and product quality.

 

ICH Q9

 

The International Council for Harmonization (ICH) Q9 states;

 

“Two primary principles of quality risk management are: the evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and, the level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk”.

 

In developing your company’s plan, you will need to consider key risk indicators and how to mitigate risk. Managing your company’s risk with a well-defined plan may help reduce strategic risk associated with poor ISO 9001 Standards. Most importantly, reducing inefficiencies associated with the product and the process is critical to improving quality.

 

A reduction in deviations/investigations, FDA warning letters, customer complaints, and product yield all improve the culture of quality.

 

Risk Management Framework

 

A risk management framework is used to evaluate all aspects of the manufacturing process and identify areas of vulnerability. These vulnerabilities need to be assessed for their financial risk impact on the operation and the potential level of risk they pose. Risk management in healthcare requires a holistic viewpoint from multiple departments across the enterprise. 

 

Quality Risk Management Plan

 

A well-written quality risk management plan is an ongoing process requiring risk control documentation throughout the product lifecycle. It provides a solid risk management process for how to improve efficiency and minimize operational risk. Focus your operational risk management on the important activities to improve product quality rather than low-risk activities that have little impact. These are four key elements to consider when defining your risk mitigation strategies:

 

Element One: Gap Analysis

The first element is to perform an analysis of the identified risk associated with the operations. For example, consider project risk management if your product is being produced using an older manufacturing line. There is compliance risk that an out of date manufacturing process will experience breakdowns.

 

Element Two: Risk Evaluation

The second step is to evaluate the risk in terms of its impact on your ability to supply a quality product. In this case, frequent shutdowns can lead to product rejections, yield loss, and potential drug shortages. Search for risk management solutions that anticipate these types of supply chain risk in advance. 

 

Element Three: Identify Controls

Once the risk has been identified and the impact evaluated, risk controls can help mitigate. For example, cybersecurity risk is a growing problem where manufacturing automation needs to be reviewed. Some of the possible mitigation control strategies might include conducting threat modeling to identify your risk in security. Ensure your risk mitigation plan also qualifies cyber risk management and how a cyber secure manufacturing line holistically prevents outside hacking.

 

Element Four: Data Management

The last key element needed is data input and management. Any risk management tool should be able to indicate if and when you need to employ one of your risk control strategies. Simple risk identification includes if you see an increase in downtime on the line or a steady decrease in yield. This data could be indicators that the manufacturing line is headed for a catastrophic failure and steps need to be taken to prevent a drug shortage situation.

 

Security Risk Management

 

The above discussion is only an example of a risk assessment in one area of an operation. Other areas of the process need to be evaluated for potential vulnerabilities and risk. These areas include an evaluation of the reliability of raw material suppliers, stability, and contractual supplier compliance, age and reliability of laboratory test equipment, etc. Supplier compliance also includes partnering with contract manufacturing organizations and contract test organizations.

 

Integrated Risk Management

 

A dynamic quality risk management plan will integrate the overall organization and identify high risk vulnerabilities. It will be proactive in identifying strategies for mitigation of the high-risk vulnerabilities. Data will be leveraged to perform continuous monitoring of the vulnerabilities. And, of course, the plan will provide the appropriate documentation and rationale for risk management programs.

 

Risk Management Consultant

 

Implementing a quality risk management plan in an organization can also be challenging. A risk management consultant can provide all applicable function personnel involved in the operations additional feedback. These functions include finance, manufacturing, regulatory affairs, purchasing, auditing, and senior management. The plan should be dynamic and should be modified as situations change.

 

Single-Source Vendor Risk

 

Let’s say you produce a product and you have a single-source supplier for one of your excipients. You have audited the supplier and have identified some significant gaps in their quality system. You identify this vulnerability in your quality risk management plan as a high-risk item because of the lack of vendor compliance.

 

One of your mitigation strategies might be to qualify an alternate supplier for the excipient. Once you have qualified that alternate supplier, you need to update your plan to downgrade the risk because you have taken the appropriate steps to mitigate it and eliminate the identified vulnerability.

 

Qualifying a Secondary Supplier

 

When qualifying a secondary supplier you may want to consider choosing a supplier in a different geographic location. There may be geographical situations or circumstances that could affect the ability of the original supplier to supply materials in a timely manner. This concept could also be applied not only to secondary suppliers of a raw material but also to suppliers of the final pharmaceutical product.

 

When choosing a new supplier in a different geographical location it will be important to understand the capabilities of the new region. The following Table demonstrates some of the information you will want to assess.

 

The chart identifies the Regulatory Agency in charge of the region you might be considering. It identifies the estimated number of employees currently in the industry and results of 2019 drug quality inspections (NAI, VAI, and OIA). Issues on Data Integrity are also tied to warning letter citations.

 

Geographic Risk Management

 

The decision to qualify a new location is a difficult one but with the proper information, it can be done.  Quality risk management plans are important because they help improve a company’s ability to provide a quality product to patients. They are contingency plans with identified actions that help to ensure a continuous supply of product to the market. Further, the risk management plan is designed to accelerate products that are safe, effective, and available.

 

They are dynamic documents that require integration into and data inputs from all departments in order to be successfully implemented at a company, require integration into and data inputs from all departments in order to be successfully implemented at a company.

regulatory compliance

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Product Launch & Lessons Learned

When medical or pharma product launch failure happens the field, everyone suffers—not just the patient, but also the manufacturer and its employees, investors, suppliers, and even competitors. No one wants a product failure, least of all the company liable for its safety.

Faced with a crisis, the manufacturer has three priorities:

  • Protect patients;
  • Resolve the problem as quickly as possible
  • Prevent the problem from recurring.

Any number of product failures can threaten a huge loss of value, above and beyond liability, to the manufacturer. If investors lose confidence and share price falls, enterprise value is destroyed. Then, as the company dedicates resources to resolving the problem, their other jobs—such as new product development—don’t get done (or, at best, don’t get done as quickly).

 

Product Failures

Pharmaceutical Innovation

Since innovation is the beating heart of the medical products and pharmaceutical industries, any delay of a new product launch can cost a manufacturer millions; in these industries, time really is money. All the more reason that speed is so important in fixing any product problem.

Yet, many—maybe most—companies are not really prepared for product failures because they lack a crisis playbook. Without a scenario-based guide, they begin and often conduct an investigation in a somewhat helter-skelter fashion, wasting valuable time figuring out what to do first, and next, and after that.

Crisis Management

The optimal time to answer those “what to do” questions is before a crisis, not in the middle of one. In our work, helping companies investigate and resolve product failures, Regulatory Compliance Associates® and The Science Cooperative have gained the following insights about what works (and what doesn’t) in managing a product crisis.

Pharma Product Launch Problems

A problem is identified as serious when field events reach some specified tipping point that indicates a trend beyond isolated incidences. At that time, the company’s leadership team has to make a few decisions: Should an official notice be released? Should the product be recalled? If yes, which markets? Should production of the product be stopped? In multiple or select plants?

Prompt action generally contributes to good will and positive publicity. The challenge at this stage is a deficit of facts since the forensic investigation itself hasn’t started. In putting together a crisis playbook, a company should begin with guidelines and policies to direct the first responders in evaluating the size of the threat and the appropriateness of various options for response depending on the apparent scope and severity of the problem.

Supply Chain

For example, if a product is one component in an assembly, perhaps the best response is for multiple supply chain owners to work together to find the optimal fix for the problem. The “point man” for making that happen could be decided in advance.

Of course, a crisis playbook would also help business leaders evaluate the cost of alternative responses. Scenario-based planning provides a context for weighing alternatives and options. Above all else, the first responders would want to stop patient harm. Every manufacturer we have worked with has agreed: protecting the safety of the patient population comes first.

Pharma Product Launch Teams

After the first responders have reviewed the situation and decided there is cause for escalation, it is time to identify a crisis manager, an investigation leader and the functional forensic team(s). In our experience, an attorney or senior executive with strong project management skills is a good choice for crisis manager. Also, each team needs at least one member with strong organizational skills.

The crisis playbook should cover roles and responsibilities—including potential action checklists—for multiple functional teams. It is feasible that a crisis might require teams in R&D, sciences, manufacturing, distribution, supply chain, human resources, legal, regulatory, quality, environmental, sales/marketing, and communications, as well as subteams for representatives from affected countries and from government affairs.

Crisis Playbook

What expertise would each team require? What would be each team’s scope and focus? Most important, how should the teams interact, coordinate activities, and measure progress toward milestones and a final resolution? A crisis playbook should provide answers, which would vary case-by-case. (See the sidebar, “Functional Crisis Planning: Roles and Responsibilities for the Crisis Team”). The crisis playbook should cover roles and responsibilities – including potential action checklists – for multiple functional teams.

Good project management skills are fundamental to managing the investigation process effectively and efficiently. Although the teams are all working on the same problem, each has its own agenda and requires its own plan and milestones. Role-based accountability for project and team-specific organization, documentation, schedules, data management, and reporting can be decided well in advance of a crisis.

In our experience, it is a best practice for the leaders of the crisis management team to meet daily and assure clear, timely, cross-functional communication, as well as to agree on next steps.

Pharma Product Launch: Crisis Roadmap

If valuable resources are taken away or distracted from their jobs to any significant degree, real and measurable enterprise value is destroyed. While leaders and experts from each affected corporate function play a vital role in an investigation, it is a smart business strategy to bring in specialists to support the effort with their expertise and experience.

FDA Investigation

In addition to minimizing damage to the company’s value and brand, the quick building up of expertise also speeds up the forensic process itself. One of our clients asked both the FDA and the notified body for its European markets to participate in an investigation. As a result, the company tripled its lab capacity and bolstered its credibility with shareholders and the marketplace at large.

Independent consultants can add muscle to an investigation, while buttressing investor confidence. As an added benefit, they can often give employees the freedom to speak without repercussion because they’re beyond the “politics” of the enterprise. Also, outside resources with the right knowledge and “know how” will be well-versed in Corrective and Preventive Action (CAPA) processes and can use this expertise to streamline and speed up the investigation.

Pharma Product Launch New Direction

pharma product launchEach team needs a directed course of action based on scenario planning. Given a set of regulatory variables that would vary by product and case—including (but not limited to) the severity of the crisis, geography, financial liability, and the possibility of substitute products—what steps should each team take to contribute to the problem identification, resolution, and ongoing prevention?

The steps required of each team can be captured in “punch lists” to minimize redundancy and duplication of effort. Then, it is relatively easy to assign responsibility for each item on the list. If the product is used in more than one country or region, the work of the corporate teams needs to be mirrored by local teams. And everyone’s findings need to roll up to the top.

Deviations

Perhaps one of the most critical points in the investigation roadmap—and the one that is most often missing—is a “stop” point. The longer an investigation goes on, the more enterprise value it can destroy. In the beginning, it’s important to decide: when is the problem solved? Is it when the contaminant is found? When the deviations in the factory or the supply chain process is fixed? Or when the product is reintroduced to the market?

Among these inquiries is another with implications for continuous improvement: why didn’t the QA processes in place (for design, manufacturing, and other functions) detect the potential failure? Scope control is a fundamental component of good project management. In most cases, there is no need to parse the product failures problem beyond a practical solution.

Crisis Checklist

The crisis playbook should include prototype action plans, checklists, work streams, decision processes, schedules, milestones, resource requirements, budgets, and documentation (see the sidebar, “Steps for Post-Crisis Resolution”).

Pharma Product Launch Communication

From day one, the crisis manager needs to share information about commitments, expectations, and progress. Communication—internally with employees and externally with investors, supply chain partners, regulatory agencies, the public, and sometimes competitors—is critically important.

Crisis Communication

The overall process needs a “point person” for communication, as does each team, whether at the corporate or facility level. The role of each communication channel—including press releases, internal newsletters or briefs, media contacts, video, and letters to shareholders and the investment community—can be planned well in advance: a crisis playbook can take chaos out of the process and enable the company to put its best foot forward.

In communication, the current best practice is a dedicated portal, a single source for real-time updates on the investigation, typically accessible through the company’s website. The old proverb “a stitch in time saves nine” captures the value of a crisis playbook: being prepared will save time and money down the road.

Key Steps in Crisis Management

Most importantly, fewer product failures could literally save lives. By being mindful of the components of effective and efficient crisis management—building up and deploying expert resources; coordinating and integrating parallel work streams; following and documenting rationalized processes—a company’s leadership can be confident in its preparedness to handle a product failure to the satisfaction of everyone’s best interests.

pharma product launch

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Quality Management System

Client

Fortune 500 manufacturer of consumer products in need of quality management system support. 

Industry

Medical Device

Business Challenge

Regulatory requirements for Design Master Record and Design History File for product launch of a new medical device

Project Timeline

3 months

About QMS for Medical Devices

The FDA Quality Management System (QS) regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Design controls for new product development are part of a Quality System. Within Design controls is the design history file (DHF) which demonstrates the product design was developed in accordance with the approved design plan and the requirements of the regulations (21 CFR Part 820.30).

Client Challenge

A fortune 500 consumer products company was planning new product development for their initial foray into the medical device space. Their product launch design team was introducing an innovative therapy for home use. Recognizing that risk insulation and speed to market would be critical for early adoption and success, the parent company decided to create a new subsidiary to develop and launch the product.

The seasoned Quality Assurance (QA) management elected to stay with the fortune 500 enterprise instead of joining the subsidiary, whereas some of the early and mid-careerists were attracted to the start-up venture. The subsidiary realized they had staff to implement but lacked QA leadership and deep medical device expertise.

Product Development Process

Regulatory Compliance Associates® Inc. (RCA) was engaged to recommend and establish a compliant Quality System. Thinking it would be faster than starting afresh, the subsidiary had initially proposed adoption of the parent company’s QS. RCA evaluated the legacy QS and found it lacking the medical device requirements. Over the course of 90 days, RCA developed a Quality Management System including the following elements:

  • Management representative role
  • Risk Management file and activities
  • Design History File including documentation of user needs and design inputs, design outputs, design verification and validation protocols and reports, and design reviews
  • Drafting and implementing QS standard operating procedures
  • Document Control and Quality Records processes and records
  • Device Master Record
  • Design Change process and records
  • Manufacturing Design transfer plans

To accomplish the resulting Quality Management System system, see figure 1 below, RCA provided the subsidiary with experts in product design, including mechanical electrical, software and user advocates, as well as experts in quality systems and design history files.

regulatory compliance

 

Results

With RCA’s outsourced QA expertise and product launch implementation staff, the subsidiary was able to launch the product without hiring expensive executives. Additionally, some of the subsidiary staff saw RCA as mentors, used this opportunity to enrich their skills, and increased their contribution to the organization.

Over time, there were some internal promotions within the QA team as RCA helped create a culture of grooming and promoting from within. The subsidiary continued their engagement with RCA to enrich their Quality Management System with subsequent phases. Most importantly, the transitional quality process control, Product Complaint Handling, CAPA, Quality Manual, Regulatory Reporting, Internal Audits, Post Production and Management Review.

As these milestones were achieved and as company sales grew, the subsidiary became attractive to investors and was sold to an established medical device company.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

 

EU Market Authorization for Sterile Medical Devices

The Sterilization Road Map to Authorization in the EU

Sterile Medical Devices must follow the regulations and standards for CE marking that went into effect May 2021. Medical devices being sold in Europe require a CE mark, even if the product is imported from outside the Economic European Area (EEA). CE marking certifies that a medical device complies with regulatory requirements under European Regulation (MDR 2017/745 and IVDR 2017/746). Upon receipt of the certification / CE mark the product can be freely marked, sold, and marketed anywhere in the Economic European Area (EEA).

​In this webinar, the strategic process of obtaining a CE mark, the defined product use and classification, as well as sterilization conformity assessment will be covered. Additionally, the interaction and experiences with contract sterilizers regarding MDR will be reviewed, including key validation information required for obtaining a CE mark for a sterile product.

Medical device manufacturers developing new products or improving the design, or packaging of new or existing products are invited to register for this free webinar to gain a greater understanding of the:

sterilization

  • The process to obtain a CE mark and certification under updated EU and ISO regulations.
  • Ensure compliance with regulations and product/process safety.
  • Understand the interactions with a contract sterilizer, for the validation process and submission requirements to obtain a CE mark for a sterile medical device.

About the Speakers

Marie-Pierre Hildebrand, RA/QA Director, EMEAA, Sterigenics.
 
After completing her master’s in Industrial Pharmacy, Marie-Pierre started her carrier as a Process Supervisor in the production of vaccines and then move to a role as a Clinical Trial Manager. After a couple of years in the Operations part of the business, she continued her education with a master’s in Management in order to take a role in Business Development. Marie-Pierre started at Sterigenics 7 years ago as the Responsible Site QA for an EO facility as well as executing the role of Qualified Person per EU regulations for pharmaceutical products. Marie-Pierre assumed the role of RA/QA Director for EMEAA 3 years ago and ensures the QA oversight of 11 EMEAA facilities for both RADIATION and GAS technologies. Marie-Pierre is also a Pharmaceutical Quality Systems Auditor. Marie’s Expertise includes Deep knowledge in both EU regulatory requirements as well as global sterilization requirements. She is listed as an EU-registered Qualified Person and Lead GMP and ISO 13485 auditor.
 
Seyed Khorashahi, Executive Head of Medical Devices, Regulatory Compliance Associates.
 
Seyed Khorashahi has more than 25 years experience leading R&D teams in all aspects of developing safety-critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy. Seyed has significant domain expertise in U.S. Food and Drug Administration (FDA) and EU standards, as well as in software systems and hardware development for medical devices. In addition, Seyed is adept at using strong analytical and technical skills to lead teams in solving sterilization problems and fulfilling the voice of the customer. He has a proven track record of efficiently deploying process improvements with extensive knowledge of 21 CFR 820 and ISO 13485.
 
 
 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

FDA Inspections: Hope is Not a Strategy

Subject matter experts from Regulatory Compliance Associates® Inc. discuss how too many organizations scramble when an FDA inspection occurs because they fail to be adequately prepared. True inspection preparedness, however, supplements internal audits with a practiced inspection process and focused behavioral training.

 

 

Internal Audit

 

While internal audits are a key component of inspection preparedness, they tend to be informal, less intense, and more focused on auditing than inspecting. True inspection preparedness supplements internal audits with a practiced inspection process and focused behavioral training for key personnel.

 

Before a FDA inspection occurs, organizations should have an inspection process in place and conduct mock inspections. Like any process, inspection readiness needs a plan that is executed, assessed, and continuously improved upon. 

 

Roles & Responsibilities 

 

The Inspection Room (Front Room) 
While inspectors often walk the facility, the inspection room provides a meeting space to review documentation and answer questions from the inspectors. In this “front room,” system owners or subject matter experts (SMEs) review and present materials to the FDA inspector. 

 

The Control Room (Back Room) 
The control room provides the documentation, interviewees, and preparation that is needed to support the inspection process. This “back room” team processes requests for information, retrieves documents from electronic systems, and also triages documents as needed. The control room is staffed with quality and technical personnel who log requests for information and alert department heads within the organization. 

Control room personnel should always:

  • Conduct a minimum of two reviews of every document prior to sending it to the inspection room:
  • Quality Review:
    • Make sure it points to valid SOPs and Work Instructions, etc.
  • Technical Review:
    • Make sure the SMEs have reviewed and are prepared to speak to the process with the inspector
  • Have back-up printers, toner, copiers and paper on hand

Some organizations appoint runners to take the data back and forth between the control room and inspection room. There are technology solutions to operationalize the inspection process as well. 

 

Behavioral Training

 

In the past, employees were often trained to give curt answers to FDA inspectors to avoid inadvertent revelations to the agency. This approach created fear and mistrust among employees, and set up adversarial relationships with FDA staff. In order to create the most beneficial inspection process environment, however, both the agency and the company need to form a partnership. Key behavioral tips for success include:

 

  • Empower the inspection and control room teams.
  • Bring SMEs into the control room to help gather data, review documents, and consult on the answer before they are summoned to the inspection room.
  • Help SMEs understand their role in the bigger picture of the inspection. Prep them on related questions that have already been asked.
  • Don’t allow an SME to bring in notes or an uncontrolled document.
  • Use the control room to debrief SMEs after meetings with the inspector.
  • Anticipate and prepare. The language used in inspector requests can provide insights. Anticipate next questions, proactively pull documents, and understand related metrics. For example, if the inspector asks about CAPA, review related documents such as open CAPAs, high-risk CAPAs, the average length of time for CAPAs, and the longest time for open CAPAs. Be prepared to answer the inspector’s next questions.

Practicing the inspection process, however, can be one of the best ways to help employees learn appropriate behaviors and response techniques. Train employees to:

 

  • Focus on the question asked; restate the question when unsure of what’s being asked.
  • Readily admit to not knowing an answer, but provide a date and time when the answer will be provided.
  • Create an environment that reinforces the positive but recognizes weaknesses, such as “we understand this is an area for improvement,” rather than “this has been a problem for a long time.”
  • Recognize the need for training across the organization on inspection readiness. Consider off-site locations as well. The FDA inspection process starts when the FDA inspector pulls up into the parking lot and interfaces with reception and security personnel. Don’t limit inspection training to just inspection and SME personnel.

 

Mock Inspections

 

Many companies conduct internal audits as part of their inspection readiness strategies. Mock inspections, however, take the next step and allow companies to actually practice the inspection room, the control room, and inspector interaction. 

 

During mock inspections, organizations set up inspection rooms and control rooms to help teams learn how to readily access documentation that would potentially be requested during an inspection. Additionally, these practice sessions give employees an opportunity to demonstrate proper behavior and interviewing techniques when working with the regulatory agency. 

 

A mock inspection can also be used to probe further on issues uncovered during internal audits. The mock Inspection team should bring in SMEs and other personnel as needed for this activity. This approach helps the organization fully understand areas needing improvement, and gives them a platform to take corrective action before the agency actually arrives.

 

Being properly prepared for inspection ensures that the inspection process will run smoother, decreases the likelihood of observations, and helps groom the organization and individuals for higher levels of future performance. 

 

Published by:

 

 

 

Medical Device and Diagnostic Industry.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Investigating Quality Deviations

Click to learn more about best practices and techniques for investigating deviations & improving pharmaceutical quality.

The pandemic created a backlog of delayed inspections in its wake, and regulatory bodies are prepared to hire additional employees and significantly increase the rate of inspections. That means an increased likelihood of your organization facing an audit, and increased importance in having an effective strategy for quality deviation audits & investigations.

quality deviation

MasterControl has partnered with regulatory experts Regulatory Compliance Associates (RCA) for an exclusive virtual event exploring best practices for investigating quality deviations. Join Sue Schniepp – RCA Distinguished Fellow for an informative event designed to help you manage quality events and effectively manage any audits that come your way.

We’ll explore strategies for:

  • Audit management and how to define root cause early.
  • Why centralized workspaces are interconnected with quality.
  • CAPA processes and quality event forms.
  • Answering interview questions about standardization.
  • Organizing source documents for audit reporting
  • Quality deviation inspection best practices

 

About MasterControl

MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner. The MasterControl Platform helps organisations digitise, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information, visit www.mastercontrol.com.

 

About RCA’s Pharmaceutical Consulting Services 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

Quality Assurance

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

Remediation Services 

Regulatory Compliance Associates has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.