GMP Compliance for Quality Control and Contract Laboratories

Duration: 75 Minutes
Even though CGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with up-to-date requirements and implementation. Quality control laboratories are considered high risk because after testing and approval, pharmaceutical drug products and APIs are released to the market without further check. That's the reason why FDA and other agencies put highest emphasis on inspections of QC and related contract laboratories.
Instructor: Dr. Ludwig Huber
Product ID: 501140
Objectives of the Presentation
  • FDA and international regulations and guidelines
  • Current inspection practices and most frequently found deviations
  • Major differences between GMP and non GMP laboratories
  • Compliance along the laboratory workflow and most critical steps
  • Developing a laboratory compliance master plan
  • The importance of a compliance team
  • Developing a project plan for step-by-step implementation
  • Implementing key requirements
    • Writing GMP compliant laboratory SOPS, training
    • Correct sampling and sample handling
    • Qualification and maintenance of equipment
    • Validation of analytical methods
    • Handling out-of-specification situations, preventive and corrective actions
    • Qualification of suppliers and reference material
    • Acquisition, maintenance and archiving of records
  • Preparation for FDA inspections
Why Should you Attend
Attend this webinar to learn the regulatory background and GMP requirements for quality control and contract laboratories and understand the difference between GMP and non-GMP laboratories. Also learn how to create inspection ready documentation.

Who can Benefit
  • Laboratory managers and supervisors
  • Analysts and technicians
  • Quality Control directors
  • All users of computer systems used in regulated environments
  • QA managers and personnel
  • GMP auditors
  • Teachers
$375
Recorded Session for one participant
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ludwig Huber, Ph.D., is the director of Lab compliance, 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 more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.


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