The U.S. FDA released the new Draft Guidance on “Data Integrity and Compliance with CGMP” in April, 2016.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speaker John E. Lincoln where he will examine related CGMP data integrity issues as discussed in the just released Draft Guidance on “Data Integrity and Compliance With CGMP”, addressing primarily Drugs, Biologics and Veterinary, but revealing the Agency’s thinking on this subject in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.
Who should attend?
- Casper E. Uldriks
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...
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