Join industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) for a free, 3-day virtual symposium May 13-15 where we explore the full product lifecycle of connected and wearable medical devices. From R&D, product design to sterilization, regulatory approval, and launch — our experts will walk you through the key considerations that can make or break the successful launch of your connected device.
This day sets the foundation by exploring early-stage development and pre-clinical readiness for connected devices. Experts will discuss R&D strategies, packaging and sterilization selection, and regulatory requirements.
Meeting Agenda (Please note, times listed below are in Eastern Time Zone)
11:00 AM – 12:00 PM So you think you’ve got a connected medical device? Development of a Connected Device
12:00 PM – 1:30 PM Packaging and Sterilization Modality Selection for Connected Devices
5-minute BREAK
1:35 PM – 2:05 PM Design Development Pitfalls in Connected Devices (30 min.)
2:05 – 3:05 PM Biocompatibility Evaluation, including a discussion on E&L for Medical Devices
3:05 – 3:30 PM 510(k) Marketing Submissions and Predetermined Change Control Plans
This day focuses on production processes, quality management, and preparing for scalable manufacturing while ensuring regulatory compliance and most importantly, cybersecurity and data integrity.
Meeting Agenda
11:00 AM – 11:30 AM Does your Quality Management System have the right capabilities to ensure that your XBU Connect Device will be safe and effective?
11:30 AM – 12:30 PM Sterilization Process Design for Connected Devices
5-minute BREAK
12:35 PM – 1:35 PM Regulatory Requirements for Medical Device Cybersecurity by FDA’s CDRH and EU’s MDR & IVDR
1:35 PM – 2:35 PM Software Development for Connected Devices
2:35 PM – 3:05 PM Medical Device Data Integrity and Accessibility Concerns
The new US Presidential Administration could bring significant impact on MedTech and pharmaceutical regulations for manufacturers and product developers. Join our expert panel of scientists and FDA consultants as they explore the potential regulatory changes. Speakers will discuss changes in several key areas, including FDA policy shifts, warning and consent letters, vaccine regulation, Artificial Intelligence in healthcare, and the supply chain.
These experts will share firsthand knowledge of ongoing discussions and emerging trends, and help you prepare changes that will shape the future of the healthcare industry.
Attend this webinar and learn:
What regulatory changes could be coming in 2025
FDA focal points in the new administration
Potential impact to the MedTech and Pharm industries
Rona has over 23 years of experience spanning the FDA and the pharmaceutical industry. She served as an FDA reviewer in chemistry, manufacturing and controls for biologics and generic drug applications, a regulatory affair professional, and as a pharmaceutical industry consultant, including support as primary liaison with FDA.
Anita Michael – Executive Principal Consultant, Pharma Compliance, Regulatory Compliance Associates
Anita has 24+ years of global regulatory and quality experience, including 16 years’ operating globally as a Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. She specializes in preparation, remediation and designing of training for individuals at all levels of an organization.
Thor Rollins – Biocompatibility Expert, Nelson Labs
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He is a participating member of multiple committees and plays an active role along with the FDA in developing standards, discussing biocompatibility methods, and voting on changes.
Alpa Patel, M.S., RM (NRCM) – Director of Lab Operations, Nelson Labs
Alpa Patel is a certified microbiologist and has been in the medical device industry for 20 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. She plays an active role with the FDA and regulatory committees in developing/changing current standards.
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].
Experts share insights on what the future may hold regarding biotech quality, regulatory requirements and quality standards for biotechnology industry.
The biotech industry has experienced significant growth in recent years. These complex therapies have evolved, and with this evolution comes new challenges in ensuring the quality of these products and the safety of the patients that use them. Quality regulations, and industry, may have to continually adapt to address these challenges.
To gain perspective on what the future quality standard holds for biopharmaceuticals and how the industry and regulators will address quality going forward, BioPharm International spoke with Anthony Newcombe with PAREXEL and Susan Schniepp at Regulatory Compliance Associates (RCA).
Quality Standards
BioPharm: With the fast development of the biopharmaceutical industry over the past 30 years, how have quality regulations adapted to address the complex nature of biologics?
Newcombe: Over the past 50 years, the industry has grown, especially due to advances in areas such as recombinant DNA and hybridoma technology, and more recently gene and cell therapies. As these advancements have occurred, new quality regulations have been developed to address the complex nature of biologics with specific quality requirements associated with viral safety, expression constructs, product characterization, and comparability.
Regulatory & Regulation
BioPharm: Are there regulatory guidelines in development for ensuring the quality of biologics in the future?
Newcombe: There is no indication that the current, published quality guidelines would not ensure the quality of biologics in the future, but it’s likely that regulatory guidance documents will continue to be revised and updated over time to adopt industry best practices and new technologies, for example the draft International Council for Harmonization (ICH) Q12 and the revised EudraLex Annex 1.
Biotech Consultants
BioPharm: Do Biotech consultants foresee science outpacing quality regulations?
Schniepp (RCA): I think science has already outpaced quality regulations. An example is the applicability of pharmacopeial methods for product testing. Many monographs utilize traditional high-performance liquid chromatography (HPLC) for testing.
Companies have migrated to ultra-high-pressure liquid chromatography (UHPLC) and other sophisticated methodology, thereby rendering compendial monographs obsolete. By the time updates are made to the pharmacopeias to capture the current technological advancements, more sophisticated equipment and methodologies are being introduced.
The industry seems to be moving toward a continuous monitoring where results regarding product quality can be achieved in real-time. The current processes used to update procedures, systems, and filings may not be able to keep pace with the rapid introduction of technological advances. I don’t think this is new.
Science has always outpaced quality regulations. When dissolution testing was introduced, it took a while for that technology to be widely accepted. I think this phenomenon is more of an issue today than in the past because science innovations are occurring at a much more rapid pace and affecting all aspects of the drug product lifecycle than 20 years ago. This rapid advancement of technology makes it harder for the quality regulation to catch up.
Newcombe: Quality regulations ensure that biopharmaceuticals are safe and effective, and in my opinion, are generally not driven by the pace of scientific advances. However, new quality regulations are likely to be required to keep up with the development of new advanced therapies, including gene and cell therapy and tissue engineering.
Some of these are autologous products using a patient’s own blood components and personalized medicines can present additional manufacturing, compliance, and regulatory challenges.
Quality Control
BioPharm: How do you see the role of the quality control (QC) unit changing versus the current quality standard?
Newcombe: I would not anticipate any significant changes to the role of the QC unit in the coming years. QC laboratories currently undertaking release testing for approved biologics using validated methods are unlikely to change their existing role significantly. There may also be a general reluctance to implement new analytical technologies used for testing of approved products due to potential regulatory impact with a continued reliance on established analytical methods.
Schniepp (RCA): I think the quality unit will evolve to be a more hands-on review of the product attributes. The quality unit will need to be equal partners with manufacturing to be able to release product quickly and solve deviations and investigations in a timelier manner than we are experiencing today. Complete investigations will still need to be performed. They will just need to be done quicker depending on the nature of the product.
Traditionally, the quality unit has reviewed the results of the manufacturing process after the work has been completed and the batch has been packaged. To keep pace with the new quality standard of products being developed by biopharma, the quality unit may need to be releasing product, performing investigations, and initiating changes in real time. This requires agile and flexible processes and systems that can keep pace with advancements.
The quality professional of the future may need to have a solid basis in science to be able to meet the demands of manufacturing. They will need to be able to quickly ascertain how a proposed change or deviation could affect the functionality and quality of a product, which will require an intimate understanding of the manufacturing and science associated with the product. To keep pace with the future, quality must be imbedded in the process and not just as the final approver for product release.
Biotech Manufacturing
BioPharm: What quality control challenges do you see developing for biopharmaceutical manufacturing
Schniepp (RCA): Quality control to me is the testing that is associated with determining if the product meets critical parameters throughout the manufacturing process and at release. The question is: Do we have the correct equipment, tests, and sensitivity to accurately assess the quality of products being developed today, and how will we deal with these intricacies as we advance more and more toward personalized medicines?
This concept should extend beyond the product testing and be assessed for the environmental support testing as well. Determining the proper tests and environmental controls as the industry moves forward will require new and novel thinking.
Newcombe: Recent data integrity requirements and guidelines have had an impact on data management within QC laboratories. This may present challenges for some organizations associated with the collection, processing, reviewing, and reporting of data and ensuring the accuracy and consistency of analytical results. The access and management of data stored on electronic systems within the QC laboratory is also likely to present continued challenges.
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 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.
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.
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.
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
Regulatory 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
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.
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
The 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.
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.
When it comes to pharmaceutical manufacturing, ensuring a strong quality culture is one way to avoid recurring GMP issues, such as data integrity. Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, and 2022 PDA Board of Directors Chair outlined the evolution of current quality culture initiatives and showcased some tools to help organizations build quality culture into GMP manufacturing operations during the Nov. 11, 2021, Redica Systems Quality Week webinar, “Past, Present, and Future of Quality Culture.”
“I think that is what we see sometimes in our industry,” she said. “We do not remember how we got some of the regulations that exist today, and we repeat our past mistakes.”
From Quality Metrics to Quality Culture
Schniepp began her presentation with a look at how quality culture evolved from the early 2010s discussion on quality metrics. Key points included the following:
On Oct. 5, 2005, CDER Director Janet Woodcock directed pharma manufacturers to build “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.” This set in motion CDER’s emphasis on quality in manufacturing.
Then, in 2012, the U.S. Congress passed the FDA Safety and Innovation Act (FDASIA). Title VII of the Act allows for risk-based inspection of manufacturing sites, including requesting records in advance, or in lieu of an inspection. Additionally, the Act requires the FDA to provide Congress with an annual report on the state of drug shortages.
Around the same time that FDASIA became effective, drug shortages became a critical concern for the agency. Schniepp pointed to aging facilities as one reason for shortages. “Tangential to metrics and quality culture, we had aging facilities, i.e., facilities producing many of the drugs showing up on the drug shortage list were degrading and not being maintained.” Quality issues at these sites had become apparent and potentially causing shortages.
In 2014, FDA proposed implementation of a quality metrics system to encourage adoption of quality-supporting practices.
GMP Manufacturing & Measuring Quality Culture
The quality metrics push resulted in a series of conferences by ISPE, PDA, and the Brookings Institution (Figure 1 below).
“One of the elements that came out of all of these discussions was the fact that you could request any metrics that you wanted. What FDA proposed initially was rejection rate on batches, CAPA rates, etc., but the conversation became that without the culture of the organization being assessed, you could not really count on the data. So, that is how [quality metrics and quality culture] tie together,” Schniepp explained.
Quality Metrics
“You needed to have a functioning, efficient, quality metric system that gives you reliable data. And you have to count on the integrity of the culture of an organization in order to have confidence in the data that it sends you. Off of that, the discussion turned to, ‘well, how do you measure quality culture?’”
GMP Manufacturing & Quality Culture Behavior
Schniepp was part of a PDA team studying the relationship between quality culture behavior and mature quality attributes to see if there was a set of mature quality attributes that could serve as a surrogate for quality culture behaviors (ISPE has also done work in this area).
“’Mature quality attribute’” refers to “those things in your quality management system (QMS) such as your CAPA program, your change control, your investigations procedures, how you report deviations, how you record batch rejection rates, i.e., all of those things are in your quality culture or in your QMS.”
Quality Attributes
But her team wanted to know if mature quality attributes related to the behaviors of employees and management correlated with company culture, such as do people feel comfortable speaking up, do they talk to management about their concerns, do they understand their jobs, etc. The team’s research resulted in what Schniepp refers to as “the Culture Equation” (Figure 2).
Figure 2
“The foundation of this is quality attributes that are quantifiable and easily measured, provided they equal quality behaviors,” she said. “In other words, you have attributes reflected in your behaviors that then define your quality culture. So, if quality cultures equal quality behaviors equals quality culture, your quality attributes equal quality behaviors equal quality culture. If you can measure your quality attributes, you can define your quality culture.”
Operational Excellence
By surveying PDA’s membership, her team gathered enough data to conduct statistical analysis and was able to determine there is a relationship between quality culture behavior and quality attributes. They then worked with another team from the University of Saint Gallen’s operational excellence program. That team also found a correlation confirming “quality attributes equal quality behaviors equal quality culture.”
The PDA and St. Gallen research resulted in the PDA Quality Culture Guided Assessment Tool, addressing five key areas in which companies should focus in order to build quality culture: Employee Ownership and Engagement, Continuous Improvement, Technical Excellence, Leadership Commitment, and Communication and Collaboration. This tool is currently under development as a PDA standard.
Quality Metrics, Data Integrity & Quality Culture
Figure 1
Data integrity is increasingly connected with quality culture. In the PIC/S guidance, Good Practices For Data Management And Integrity in Regulated GMP/GDP Environments, “they have defined quality culture, and they have given us a little bit of information about how management can create a work environment—a culture—that is transparent and open.”
Schniepp also pointed to three other documents:
UK MHRA GxP Data Integrity Definitions and Guidance for Industry
WHO Guidance on Good Data and Record Management Practices
FDA guidance Data Integrity and Compliance With Drug CGMP Questions and Answers
“In their regulations, regulators are starting to define and link culture to data integrity violations,” she explained.
Data Integrity
She then provided a real-life example of a data integrity violation caused by a company’s culture.
“This one is kind of an interesting one because it was really an attempt by management to encourage employees to do a good job, but what they did created integrity violations.”
A contract manufacturing organization (CMO) set a GMP manufacturing goal to release batch records to clients within 30 days of manufacturing the product. To encourage this, management dangled the carrot of a pizza party at the end of the year if this goal was met. In order to meet this goal, employees released batch records to clients even if investigations had not uncovered the root cause. Investigations would be prematurely closed and then reopened after the batch record had been sent to the client.
“That, in and of itself, is a data integrity nightmare,” Schniepp said. “Can you imagine explaining in an audit by a regulator, ‘well, we wanted a pizza party?’”
GMP Manufacturing & Organizational Culture
Regarding deviation investigations, she told another story of a company for whom she worked that involved repeat observations. When reviewing deviations, she found that one operator had 30 deviations tied to him involving a specific product. This operator failed to sign the batch record during a specific point in time in manufacturing. His managers kept retraining him.
[Author’s Note: Additional information about deviation investigations can be found in the articles, “GMP Inspection Case Study Focuses on Inadequate Deviation Investigations” and “How to Avoid Three Common Deviation Investigation Pitfalls.”]
Batch Records
In talking with the operator, Schniepp learned that in order for the operator to sign the batch record (according to GMP regulations at that particular point in manufacturing), the operator had to leave the product alone in the equipment, de-gown, sign the batch record, re-gown, and return, all the while hoping the product was okay. Out of concern for the product, the operator chose to stay behind and try to remember to sign the batch record once he was done.
“It was a poorly designed batch record process,” she said. But the operator did not feel listened to when he brought his concerns to management.
GMP Labeling
Schniepp then pointed out that other employees worked on the product under the same cGMP constraints. So, what were these other employees doing? How many other data integrity violations occurred? Was GMP labelling reviewed accurately?
“Nobody else was bringing it up. If you do not have that open culture, if you are not encouraging people to speak up and you are not listening to them, you do not have a good quality culture.”
The Future is GMP Manufacturing Quality
For further evidence of the importance of GMP certification and quality culture, Schniepp reviewed a 483 observation issued in 2019 with numerous examples of data mismanagement. The company in question then responded to FDA with a letter promising to ensure a robust quality culture going forward. [Author’s Note: For more about this GMP compliance incident, read the first case study in the article, “Data Integrity Concerns Discovered in Gene Therapy Product Submissions,” by Jerry Chapman.]
FDA 483
Schniepp believes this 483 observation shows FDA’s intent to heavily focus more on good manufacturing practices in future inspections. This means companies must develop or enhance their quality culture when thinking about how to prepare for upcoming inspections.
“I believe we will see more of this,” she said. “More companies will be looking at their GMP manufacturing and trying to improve the Quality Culture.”
Otherwise, as she explained at the beginning of her presentation, companies who remain in the past when it comes to cGMP certified practices that lead to quality culture face the prospect of 483 observations, Warning Letters, and other negative outcomes.
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 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.
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.
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.
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
Regulatory 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
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.
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.
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.
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 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.
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.
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.
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
Regulatory 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
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.
The biotech industry has experienced significant growth in recent years. These complex therapies have evolved, and with this evolution comes new challenges in ensuring the quality of these products and the safety of the patients that use them. Quality regulations, and industry, may have to continually adapt to address these challenges.
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