HUM-MOLGEN events: Understanding and Preparing for FDA's New Part 11 Inspection Program

Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections.

Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry.

Reference material for easy implementation:

25 recent FDA Warning Letters with part 11 violations.
15 Case Studies: Implementing Part 11
Validation templates and examples

Areas Covered In the Seminar:

FDA inspections: Preparation, conducts, follow up
Learning from past Part 11 inspections
Scope of the new Part 11 program: time frame, expected outcome
Criteria for selection of target companies
What inspectors are looking for
How to prepare your company for the upcoming inspections
Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations
How to fill gaps short term
Developing a program for long term
Creating the right documentation to satisfy the inspectors
Most likely next steps after the inspection program

Who will benefit:

IT managers and system administrators
QA managers and personnel
QC and Lab managers
Validation specialists
Regulatory affairs
Training departments
Documentation department
Consultants

Understanding and Preparing for FDA's New Part 11 Inspection Program - Webinar By GlobalCompliancePanel