Virtual Audit & Inspections

Companies in almost every industry across the world have had to adjust due to the pandemic by moving key face-to-face activities during a virtual audit. In this episode of RCA Radio, host Brandon Miller and guest Steven Lynn, Regulatory Compliance Associates (RCA) Executive Vice President of Pharmaceuticals, discuss Virtual Audit and Inspections.

Listen in as we address how the FDA performs virtual audit and inspections, some best practices for conducting these audits and inspections, as well as how companies can prepare for this type of remote work.

About RCA’s Compliance Services

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance Associates^® Inc. can help. Our subject matter experts are internationally known in the regulatory compliance consulting industry.

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA^® Inc., we offer the pharmaceutical consultants and resources necessary to guide you in regulatory compliance.

We’re In Compliance

From family-owned enterprises to multinational Fortune 100 companies, we work with all types of pharmaceutical businesses. RCA^® Inc. is a certified ISO 9001 organization: we understand navigating the changing demands of the FDA and other regulatory agencies.

Over 500 industry experts, FDA veterans and consulting professionals oversee our services to ensure that your business is protected to the fullest possible extent. Regulatory policy is what we do – and we do more of it than anyone we know.

Assessments

The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA^® Inc., our FDA compliance consulting experts have decades of experience in both regulatory compliance program strategy and execution. We’ll help you measure your quality system with FDA regulations to assess any process weaknesses and opportunity to improve.

Our range of compliance regulatory services include:

cGMP
Quality Infrastructure
PAI, Validation
Facilities and Maintenance
Laboratory (GLP)
Process Assessments to Streamline and Optimize New and Existing Systems.

Audits

Periodic regulatory audits are necessary to both ensure the continued quality regulatory compliance of your organization. An internal audit helps maintain your readiness for an FDA inspection — and we have the resources to help. Our experienced team of ASQ-CQA and RABQSA certified auditors is available to perform a range of internal audit services, including:

Supplier
API
Contact Manufactures (CMO)
Internal
Quality Systems
Baseline
Verification
Clinical (CRO) and Clinical Manufacturing
Data Integrity
503A & 503B
Combination Products

Regulatory Agency Response

Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. We can assist you in developing a customized response and plan of action to help remediate the effects of a FDA 483 warning. Our compliance and regulatory services team is here to provide the guidance you need most during this time, with response solutions for:

FDA Form 483
Warning Letter
Consent Decree
Import Bans

Preparation, Training, and Inspection Readiness

Sitting back and hoping for your next FDA inspection to go well isn’t an option — you need active preparation and training tailored to your needs and business goals. RCA^® Inc. will help you thoroughly prepare for inspections with an extensive range of training programs, mock inspections and other readiness solutions, such as:

Mock Inspections
- Back Room/ Front Room set-up and process
- Inspection Analysis & Report
Response Letter Assistance
Proof Book Development
Business Relations (Leadership Development Training)
- Corporate Regulation Examples
  - Regulatory Law
  - Regulatory Board
  - Legal Compliance
Industry Relations (Leadership Development Training)
- Types of Regulation
  - Medical Regulations
  - Security Regulations
  - Cybersecurity Regulations
  - Data Compliance Regulations

About RCA

pharmaceutical consultants Regulatory Compliance Associates^® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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-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

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