Data Integrity 2021 - Cybersecurity, Data Integrity, Part 11, and Required Software Validation Training

This webinar will focus on their expectations for industry. Data Integrity has always been a CGMP priority; Cybersecurity is coming under increased regulatory review. The Agency leaves the how of compliance up to the manufacturer
Data integrity has always been a key component of all the CGMPs, only now taking on greater emphasis due to the use of electronic records / signatures. Cybersecurity is the preventing the theft / modification of e-records by unauthorized access.
Key Guidances on Cybersecurity
Draft Guidance on Data Integrity
How the CGMPs are Affected
Speaker:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 39 years experience in U.S. FDA-regulated industries, 25 of which as head of his own consulting company.