Implementing 21 CFR Part 11 Regulations – A Practical Approach - Webinar By ComplianceOnline (Pharmaceuticals Trai)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: May 19, 2011 End Date/Time: May 19, 2011
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Why Should You Attend:

The quality of electronic systems for manufacturing, laboratory and clinical use is carefully regulated by the FDA through implementation of regulatory requirements. Technology is advancing rapidly and ensuring compliance and FDA requirements presents a challenge. The 60 minute webinar will focus on the requirements for proving validation compliance standards for the applications and computerized systems utilized in GXP industries.

Areas Covered in the Seminar:

- The importance of Regulatory Requirements and who must comply
- The FDA’s Perspective: 21 CFR Part 11 Compliance and Computer Validation
- Risk Analysis – How to Determine Which Systems Need to be Validation
- Procedural Requirements for Data Migration, User Requirement Specifications, Design Specifications
- Developing the Validation Master Plan
Preparing Reports

Who Will Benefit:

- Information Technology Managers & Professionals
- Quality Assurance Staff
- Quality Control Staff
- GMP, GCP, and GLP Professionals
- Regulatory Affair Managers & Staff
- Clinical Data Management Professionals

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.


Online Event
2600 E. Bayshore Road
Palo Alto
United States