FDA's New Draft Guidance on Data Integrity for CGMP Compliance

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Understanding the implication of FDA’s New Draft Guidance on Data Integrity for CGMP Compliance

The U.S. FDA released the new Draft Guidance on “Data Integrity and Compliance with CGMP” in April, 2016. There remains some confusion as to the FDA’s current thinking with respect to electronic records and/or electronic signatures and their interpretation of 21 CFR Part 11.

Do you know what does the FDA currently expects in view of its stated narrow scope and application of Part 11, pending FDA’s re-examination of part 11 as it applies to all FDA-regulated products?

Join expert speaker John E. Lincoln where he will examine related CGMP data integrity issues as discussed in the just released Draft Guidance on “Data Integrity and Compliance With CGMP”, addressing primarily Drugs, Biologics and Veterinary, but revealing the Agency’s thinking on this subject in general.

Learning Highlights:

  • Understand key data terms and the FDA’s definitions
  • Recognize Data that must be retained and what may be excluded from decision making
  • Familiarize themselves with V&V requirements for data
  • Come to terms with control of software, hardware, personnel and documentation
  • Know restricted access / log-ins
  • Understand blank forms controls
  • Discuss audit trails
  • Become familiar with use of e-records and/or e-sigs
  • Understand consequences of paper print-outs
  • When does e-data become a CGMP record?
  • What are acceptable lab records?
  • Treatment of altered records
  • Training
  • FDA inspections and resolution of data integrity problems

Session Agenda:

  • Overview of the draft Data Integrity Guidance
  • Definitions
  • What is CGMP Data?  Company Usage?
  • FDA's Current Narrow Scope and Application of 21 CFR Part 11 (ER and ES)
  • FDA expectations for a Company's Data Integrity Assurance Systems - Access, e-records / e-signatures
  • Lab Data Issues
  • Potential Problem Areas and their Resolution

Who should attend?

  • Senior management in Drugs, Devices, Biologics, Combination products, Dietary Supplements, and Veterinary
  • QA
  • RA
  • Engineering
  • R&D
  • Production
  • Operations
  • Consultants; others tasked with product, process, validations, CGMP responsibilities
  • Useful for members of AQC, RAPS, AAMI, etc.

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About Our Speaker

John E. Lincoln

John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...   More Info
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