Use GAMP to Surefire your CSV Audit

Description: Regulatory agencies have stepped up audits to aggressively enforce computer systems validation (CSV) and CFR 21 Part 11/Annex 11 implementation. A third of recent warning letters have cited improper validation and/or incorrect or deficient implementation. After a walkthrough of regulations for CSV, the presentation will transition to a brief explanation of validation enablers as enumerated in ISPE’s GAMP V guide to include the V-model and ASTM’s E-2500 standards. Finally, the webinar addresses e-Validation and their impact on ensuring that

Validation is no longer a costly and risky activity. Regulations require validation of medical devices and computer systems used in the production of pharmaceutical and biotechnology products. However, the regulations do not provide a framework for validation. GAMP is a framework devised by industry professionals. It is being used for computer systems validation by companies worldwide. It’s use is considered to be a significant factor in trouble free audits. Why Should you Attend: This webinar demonstrates the use of GAMP to determine what needs to be validated, the amount of validation that is required and how to establish a documentation strategy for

recording the validation outcomes. It also covers proven techniques for creating documents that meet regulatory requirements.

Objectives of the Presentation:

At the end of the webinar, participants will: o Become aware of document requirements for Computer Systems Validation

o Understand how GAMP’s framework fulfills regulatory requirements

o Understand the basics of CSV and related regulations

o Become familiar with CFR 21 Part 11 validation issues

o Review some CSV related 483s and WL

Who can Benefit: o QA

o QC

o Engineering

o IT Personnel

o Manufacturing

o Validation Consultants.

o

Wednesday, January 16, 2013

10:00 AM PST | 01:00 PM EST

Live Session for one participant

Price: $243.00

Corporate Live Session 3 to 4 participants in single location. (For muliple location contact

customer care)

Price:$486.00

Corporate Live Session 5 to 10 participants in single location. (For muliple location contact

customer care)

Price:$986.00

Recorded Session Access recorded sessions only for one participant unlimited viewing for 6

months.

Price: $288.00