Data integrity has been a current focus for regulatory audits in the last few years. Correct setup and configuration of computerized systems used in a GMP environment is critical to ensuring compliance.
This webinar will provide an overview of the most common observations on CSV systems related to Data Integrity as well as review CSV concepts and best practices to ensuring compliance as they apply to the Pharmaceutical Industry.
Summary of highlighted points to be covered:
- The need to be compliant
- What is Data Integrity?
- Regulations and relevant GMP’s
- Observations- FDA, EU
- CSV Concerns (security, metadata & audit trail, static vs dynamic data, data archiving & backup, systems)
- Best practices
**A Certificate of Completion will be sent to each registered Attendee following the webinar**
WHO SHOULD ATTEND?
Personnel working within a GMP environment and involved in:
- Computer Systems Validation
- System Use
- Audit or Configuration
- Support (ie- system users and owners)
- Validation staff
- Quality staff
- Information technology staff
David McSweeney BSc, AIT is a subject matter expert for Computer System Validation. He has been working in the Pharmaceutical industry for 24 years from Research, Production, Information Technology, Project Management. He has lead projects for multinational pharmaceutical manufacturers including Sanofi Pasteur, GSK Biologicals, Teva, Apotex, Therapure BioPharma, Boehringer Ingelheim, MDS Pharma Services / Clearstone Labs in the United States, Canada and Internationally. David is an expert in Project Management and GxP, specializing in IT Projects, Quality Management, Data Integrity and 21 CFR Part 11 compliant computerized systems. He has successfully worked on a variety of Computer Systems Implementation projects in manufacturing and research laboratories validating infrastructure, standalone computerized lab instruments and complex global networked systems.
|Student Ticket:||$100.00||— Sold Out|
|Basic Member Ticket:||$210.00||— Sold Out|
|Pro/Pro Plus Member Ticket:||$180.00||— Sold Out|