Current Regulatory and Compliance Trends in the Area of Consent Decree in Pharmaceutical, Medical Device and Biologics Webinar
Time: 10:00 AM PDT, 01:00 PM EDT
Duration: 90 Minutes
Instructor: Gaurav Walia
This webinar will focus on current Food and Drug Administration (FDA) regulatory guidance as well as current regulatory trends with regards to specific Consent Decrees.
This webinar will focus on key Quality Systems that are being highlighted in many of the Consent Decrees, such as Computer Systems Validation (focusing on 21CFR Part 11, Electronic Records and Signatures (ERES), Equipment Qualification, Change Control Systems, Proper Laboratory Investigations, Corrective Action/Preventative Actions (CAPA), Root Cause Analysis (RCA), etc. Overall, this webinar/course will provide the attendees with the ultimate set of tools in order to help their firms during a Regulatory Inspection as well as helping to avoid falling under Consent Decree Status.
Why Should you Attend:
In the recent past there has been an explosion of Regulatory enforcement specifically involving Consent Decree. This webinar is directed towards executive management, Quality Assurance, Quality Control and Regulatory and Compliance staff who are involved in Consent Decree projects.
Objectives of the Presentation:
- Learning about the history of Consent Decrees
- Discussing the Schering Plough historical Consent Decree case
- Key Quality System examples highlighted in many Consent Decrees
- Computer Systems Validation focus
- 21CFR Part 1
- ERES (Electronic Records and Electronic Signatures)
- Current Domestic Food and Drug Administration regulatory trends
- Global regulatory enforcement activity
- Summary of lessons learned during regulatory enforcement/Consent Decree