FDA Recordkeeping Requirements
More than 35% of FDA warning letters cite poor record and document controls. And in the first part of 2012, FDA cited five companies just for poor recordkeeping of regulatory records.
More than 35% of FDA warning letters cite poor record and document controls. And in the first part of 2012, FDA cited five companies just for poor recordkeeping of regulatory records:
- Ningbo Huahui Medical Instruments
- Campania Internacional de Comercio
- Health One Pharmaceuticals
- Edge Biologicals
- Gulf Pharmaceuticals
The ugly truth about FDA compliance is that the agency doesn’t care what you say you did, FDA investigators only look at the records and documents you’ve kept. You cannot hope to pass an FDA inspection without the right records.
So what sort of recordkeeping policies do you need? What should be in your SOPs to allow crystal clear record generation and retention? How do you find out what you need to keep? And what do you do when FDA asks for records held by your supplier or stored in email or in archive?
Webinar Includes:
- 11-step recordkeeping strategy sheet Checklist of core recordkeeping controls – perfect for adopting into quality and supplier audits
- Q/A Session with the Expert to ask your question
- PDF print only copy of PowerPoint slides
- 90 Minutes Live Presentation
Description of the topic
Learn the SOPs and policies to have, how to incorporate risk assessments, how to ensure each of your SOPs generate clear records as proof of compliance, and get the details of an effective FDA recordkeeping program. Learn the types of documents FDA expects you to retain, and where to go to identify the specific documents, correspondence, and records your company is required to keep.
Areas Covered In the Seminar
Types of regulated records required to be kept
How to determine what documents you need to retain and for how long
Example FDA enforcement citations for poor recordkeeping practices
How to develop an FDA records retention schedule
How to handle records maintained at your suppliers
How to deal with email and records kept electronically vs. in hardcopy
SOPs and policies you need to have
Who will benefit
Quality managers and professionals
Regulatory affairs managers and professionals
Document control/records management professionals and managers
Anyone interested in being able to prove compliance to the FDA investigator or a mock FDA auditor
About Speaker
John Avellanet is an award-winning FDA compliance expert.
He serves as the IRO for a major consent decree, is the lead author of several certification courses for the US Regulatory Affairs Professional Society, and has recently published the book Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (Logos Press).
In 2009 and 2011, Mr. Avellanet won the “Best of Business” award from the US Small Business Commerce Association. His blog, ComplianceZen.com, has been repeatedly named one of the “Top 50 Blogs” worldwide on FDA compliance issues.
Over the past 6 years, he has been interviewed on public radio programs and in numerous industry magazines. He speaks frequently for industry conferences and corporate workshops. Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, Mr. Avellanet was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance. During his career, he had to defend decisions to investigators, auditors, and litigators alike. He now brings all of that hard-won, real-world experience and practical advice to his corporate clients worldwide. To date, he has saved his clients an average of $1.2 million each and kept them out of trouble with FDA, EMA and other regulatory agencies.
A former US Department of Justice prosecutor has said of Mr. Avellanet, “He is the best in the business. Period.”