Auditing QC and Contract Laboratories for GMP Compliance

Why Should You Attend:

Quality control laboratories are considered high risk since, after testing and approval, pharmaceutical drug products and APIs are released to the market without further check. It's also the reason why FDA and other agencies lay heavy emphasis on inspection of QC laboratories. The large number of recent QC related 483s and warning letters prove that companies have issues in complying with regulations. Auditing laboratories is an ideal tool to verify compliance of laboratory practices with regulations and to prepare your organization for regulatory inspections. This webinar will help attendees learn how to use internal audits of QC laboratories as excellent preparation for FDA inspections. The instructor will also offer best practice guidelines for effective implementation.

Areas Covered in the Webinar:

• Why are internal audits important
• FDA and international requirements for laboratory audits
• FDA and EMA inspections as models for laboratory audits
• Developing an SOP for 'FDA Inspection Like' audits
• Developing an audit schedule
• The audit team: members, tasks, responsibilities
• Most critical audit areas based on risk assessment
• Looking at the right documentation
• Auditing the laboratory quality system
• Audit items along the sample and data workflow from sampling to record archiving
• Assessment through laboratory walkthrough
• The importance of the exit meeting
• Writing the audit report
• Follow-up with corrective and preventive actions: Going through six case studies

Who Will Benefit:

• GMP auditors – internal and external
• Lab supervisors and managers
• Analysts and other laboratory staff
• QA managers and personnel
• Training departments
• Consultants

Instructor Profile:

Ludwig Huber, Ph.D., is the director of Labcompliance, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

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