Having quick and easy access to your most important documentation is essential for a successful regulatory inspection. With the FDA now looking at records electronically — either on site or remotely — the need to always be “inspection ready” has increased exponentially.

Not knowing where a document is, producing the wrong document or not understanding what you must provide vs. what is discretionary — and what areas are off limits to the FDA by law — inhibits your ability to respond promptly and effectively.

In this FDAnews webinar, internationally recognized inspections expert David Chesney, principal and general manager of DL Chesney Consulting, will teach you how to optimize and organize your records for your next inspection or remote regulatory assessment while avoiding pitfalls in data retrieval, improper or missing documentation, or electronic data transmission errors.

Webinar Takeaways:

  • Understand the types of documents commonly requested during inspections and remote assessments.
  • Handle paper documents properly and provide investigators with access to electronic source data without compromising security.
  • Learn the top 10 questions to ask about your archival process.
  • Know the perils of emails as documentation and how to avoid them. 
  • Recognize the difference between copies and originals and what FDA regulations require.

Arm yourself with the knowledge needed to ensure a successful FDA inspection or remote records review.

Who Will Benefit:

  • QA/QC managers and staff
  • Document managers and staff
  • Senior leadership team members
  • Regulatory affairs managers and staff
  • IT managers and staff
  • Lab managers and staff
  • Project coordinators
  • Principal investigators
  • Legal counsel