Auditing QC and Contract Laboratories for GMP Compliance

Instructor: Dr. Ludwig Huber
Product ID: 703808
  • Duration: 75 Min
This course will explore why auditing laboratories is the ideal tool to verify compliance of laboratory practices. It will guide attendees in preparing for FDA inspections, while detailing documentation requirements for the FDA and ISO.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2020

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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.

Follow us :
Laboratory Inspection and Auditing
Lifecycle Management of Analytical Methods and Procedures

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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