FOOD SAFETY 2011 - Understanding and Implementing FDA’S 21 CFR Part 11

Website http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=701867?channel=ourglocal | Edit Freely

Category Food Safety,conference,event,Webinar

Deadline: February 08, 2011 | Date: February 08, 2011

Venue/Country: Palo Alto, U.S.A

Updated: 2011-02-02 15:13:09 (GMT+9)

Call For Papers - CFP

In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even the rule is more than 10 years old there still many questions related to the scope and real requirements of Part 11.

Attend this 21 cfr part 11 webinar to get a good understanding of current and future FDA requirements and provide steps, examples and tools for cost-effective implementation.

Areas Covered in the Seminar:

Overview on Part 11 history and requirements

Current and future FDA inspections with focus on computers and electronic records

Part 11 requirements that are NOT enforced any more

Going through individual requirements:

Validation

limited authorized access to system and data

archiving and retrieval of e-records

executing electronic signatures

binding signatures with records, training

Recommendations for implementation and documentation

Bringing existing systems into compliance with minimal effort

Responsibilities of vendors and users

Going through most common pitfalls

Going through frequently asked questions and answers

Preparing for Part 11 Inspections

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