Preparing for Pre-Approval Inspections

Pre-approval inspections (PAIs) by the FDA are conducted to ensure that a manufacturing facility named in a drug application can produce the product as described in the application and that the data submitted is accurate and complete. PAIs are a key part of the FDA's drug approval process, helping to verify the reliability of manufacturing processes and data. PAIs assure manufacturing facilities can manufacture the drug product as outlined in the New Drug Application. They verify accuracy of the manufacturing processes, quality control and stability testing. They verify the manufacturing facility is compliant with Good Manufacturing Practices, and that the data related to stability, manufacturing and quality control is reliable and authentic.

This course will provide instruction on the purposes of FDA pre-approval inspections, mock audits and how to perform them. It will teach PAI objectives, and how to effectively prepare your facility and employees for PAI audits and inspections. You will also learn about product and process specific risks.

Failing a Pre-Approval Inspection (PAI) can lead to significant consequences, including approval delays, financial losses, reputational damage, and increased scrutiny in future inspections. These risks stem from the PAI's role in verifying a facility's ability to consistently produce a safe, effective, and high-quality product.

1. Approval Delays - The FDA may withhold approval of a drug or device until all issues identified during the PAI are resolved. This can significantly impact the timeline for market entry and commercialization.
2. Financial Impact - Delays in product approval can lead to significant financial losses for companies, including lost revenue, increased development costs, and potentially higher remediation expenses.
3. Reputational Damage - Failing a PAI can erode investor confidence and damage a company's reputation, making it harder to secure future partnerships and funding.
4. Increased Scrutiny - Companies that fail a PAI may face more rigorous inspections in the future, potentially leading to increased costs and operational challenges.
5. Lack of Assurance in Product Consistency - If a facility cannot demonstrate the ability to consistently produce a product with the same safety, identity, strength, quality, and purity, the FDA may question the ability to manufacture the product in a controlled manner.

• Purpose of PAIs
• When the FDA performs PAIs
• Facility Risk, Process Risk and Product Risk
• Mock Audits
• PAI readiness steps
• Outcomes of PAIs

This webinar is for the following professionals working in a regulated environment.

• Quality Auditors
• Compliance Officers
• Managers/Directors/Supervisors and Personnel Related to:
  • Regulatory Compliance
  • Regulatory Affairs
  • Quality Control
  • Quality Assurance
  • Research and Development
  • Project Management
  • Production/Manufacturing
  • Risk Management
  • Complaint Handling
  • Personnel who are new to the regulated industry
  • Document Control

Instructor Profile:

Joy McElroy

Principle Consultant, Maynard Consulting Company

Joy McElroy has 10 years of experience as a consultant and over 30 years of total experience in the pharmaceutical and biotech industries. Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, and equipment qualification. She worked in Quality Control and Quality Assurance for several years before moving into validation and qualification. She has written and executed equipment qualification and validation protocols for numerous companies.

Ms. McElroy specializes in manufacturing equipment qualification, sterilization, cleaning validation, analytical instrument qualification, computer system validation and GMP compliance auditing. In 2019, Ms. McElroy started her own company, McElroy Training and Consultancy. She currently works with Actalent Services, LLC.