Disaster Recovery And Business Continuity Planning: Ensuring Compliance With Annex 11 & 21 CFR Part 11
This approximately 90 minute webinar describes the key portions of each regulation that require the recovery of regulated records, even after disastrous events of varying levels of severity.
This approximately 90 minute webinar describes the key portions of each regulation that require the recovery of regulated records, even after disastrous events of varying levels of severity. It explains methods for ensuring your organization has documented plans that enable recovery from the initial disaster, and allow the organization to continue to the point of full business functionality.
Webinar Includes:
- Q/A Session with the Expert to ask your question
- PDF print only copy of PowerPoint slides
- 90 Minutes Live Presentation
Why you should attend:
Annex 11 raised the bar on the use of computerized systems for GMP regulated activities, beyond the prior standard for record retention and retrieval and beyond 21 CFR Part 11. If your disaster recovery and business continuity planning has not kept pace, you may be out of compliance. While the primary focus is on compliance, the concepts are applicable beyond the manufacture of drugs and drug products regulated by the FDA and the EMEA.
Who will benefit:
This webinar will provide valuable assistance to organizations involved in the manufacture of GMP regulated drugs and drug products in the US and European Union. The employees who will most benefit include: Executive Managers
- Information Technology Directors & Management
- Manufacturing Automation specialists
- Document and Records control Management
- Quality Assurance and Regulatory Affairs Personnel
- Auditors
Areas Covered:
- Overview of the record retention and retrieval portions of 21 CFR Part 11
- Overview of the Annex 11 requirements for record retention and Business Continuity Planning
- Discussion of the differences between Disaster Recovery and Business Continuity
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Strategies for effective Disaster Recovery Planning (DRP) and Business Continuity Planning (BCP)
- Plan, do, check, act
- Common mistakes to avoid
- Ensuring the DRP and BCP meet regulatory and auditor expectations
About Speaker
Ms Preziosi is the president and principal consultant of Get Compliant, Inc. Ms. Preziosi is an accomplished Senior Consultant with over 20 years experience in a variety of Information Management and Compliance settings including: Validation, Auditing, Quality Assurance, and full SDLC Project Management in support of a wide range of GLP, GMP, GCP and QSR applications. Ms Preziosi is an ASQ certified BioMedical Auditor. She holds a Master’s Degree from the Temple University School of Pharmacy QA/RA program and has been an instructor in the program since 2007.