New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid?
Product Details
Perplexed by remote and hybrid audits? Will on-site inspections return? Among the things the pandemic upended are conventional good manufacturing process (GMP) inspections. And the FDA and other agencies are forging ahead to build new inspection models.
The lessons regulators are learning today will inform how they conduct inspections tomorrow. Whether it’s virtual, hybrid or on-site, New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid? will ensure your future inspections — in all forms — go well.
Will inspectors examine things remotely they would not on site? Does a regulatory document review carry the same weight as a traditional inspection? What are the implications for security of protected health information?
This management report prepares you for whatever the future brings. It explains what regulators expect to see and do in a remote audit (documents, records, staff interviews, virtual tours), how to prepare for new technical requirements and how communication differs. You’ll also gain insight into on-site inspections.
New Inspection Models will explain how to handle all kinds of inspections with ease.
Management report takeaways:
- How regulators will choose which manufacturers to inspect
- How often you can expect to be inspected in the post-pandemic era and whether there will be extra steps (reviews, meetings) between inspections
- Guidance from the FDA and the EMA on dealing with remote inspections
- Different types of audits and how to prepare for them
- Effective document and data integrity control
- How to view a virtual inspection from both the regulator’s and the manufacturer’s perspectives
In the pandemic, the FDA and other agencies are making the rules for GMP inspections as they go. New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid? provides everything you need to stay steps ahead now and going forward.
About the Contributors
Sue Schniepp, distinguished fellow at Regulatory Compliance Associates, is a data integrity expert who has served on the board of directors of the Parenteral Drug Association (PDA), as the PDA/FDA Joint Regulatory Affairs conference chair and as chair of the PDA’s Regulatory Affairs/Quality Advisory Board. She has also been a PDA conference presenter and was awarded PDA’s Distinguished Service Award.
Seyed Khorashahi is executive vice president of medical device and CTO at Regulatory Compliance Associates. He has more than 25 years’ experience leading R&D teams in all aspects of developing safety-critical medical devices. Khorashahi has held leadership positions at Covidien (Medtronic), Baxter and Beckman Coulter, and has an extensive background in medical device product development, quality systems, regulatory affairs and mergers and acquisitions.
Steve Lynn, principal consultant/owner of Lynn Consulting, has more than 20 years’ quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. He served in executive leadership roles with global accountability in the private sector as well as at the FDA. Lynn is an expert in GMP compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues.
Who Will Benefit
- Quality staff
- Regulatory affairs staff
- Manufacturing supervisors
- Senior executives
Add to Cart
Contributors:
Sue Schniepp, Seyed Khorashahi and Steve Lynn
ISBN-13:
978-1-60430-174-8
Publication date:
Nov. 2021
Page count:
114
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.