Quality Control Lab Compliance: Virtual 2-Day GMP and GLP Training

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DUBLIN, May 26, 2022 /PRNewswire/ — The last days to register for the course “Quality Control Laboratory Compliance – cGMP and GLP Training” have been added to from ResearchAndMarkets.com offer.

This course will review the basic requirements for all QC laboratories subject to FDA inspection, recent trends in FDA inspection reports, and enforcement actions.

FDA’s inspection and monitoring of quality control (QC) laboratories are essential components of the agency’s assessment of the compliance status of regulated companies representing multiple industries – pharmaceutical, biologics, devices medical, as well as food and cosmetics – as well as the contract QC labs that service these industries. Lack of compliance can result in severe regulatory action, criminal liability, fines, and the inability to obtain product approvals.

In addition, this course will include a list of relevant regulations and guidelines and demonstrate how Quality Control and Quality Assurance personnel can monitor industry practices to stay “up to date” with FDA requirements (cGMP and GLP ).

Learning objectives:

  • The basics of FDA law and regulations governing quality control laboratories responsible for testing research materials, components of FDA-regulated products, and FDA-regulated finished products (pharmaceuticals, biologicals, medical devices , cosmetics and food).
  • Laboratory organization, personnel qualification and training requirements.
  • Documentation and record keeping requirements, including electronic records and data integrity.
  • Sample integrity requirements.
  • Management and control of stability studies (shelf life).
  • Verification and validation of analytical methods.
  • Management and control of laboratory instruments.
  • Management and control of laboratory supplies.
  • Good conduct of laboratory investigations.
  • Consequences of laboratory non-compliance.

Main topics covered:

DAY 01 (9:00 a.m. – 5:00 p.m. CDT)

10:00 AM: Start of session


Basics of FDA Law and Regulations for Quality Control Laboratories

    • Medications
    • Organic Products
    • Medical equipement
    • food
    • Beauty products
  • What is CGMP?
    • Medications
    • Organic Products
    • Medical equipement
    • food
    • Beauty products
  • What is GLP?
  • What is AIP?
  • Contract laboratories
  • FDA Inspection Methodology

Organization of the laboratory

  • Organization
  • Staff qualification and training

Documentation and record keeping requirements

  • Standard Operating Procedures
  • Analytical methods
  • Raw data (books, impressions)
  • Document management (change control, retention)
  • Part 11 (electronic records and signatures)

Sample integrity requirements

  • Sample collection
  • Delivery, handling, disposal of samples
  • Store samples

Stability studies (shelf life)

  • Organization and management
  • Storage units
  • Analytical methodology

DAY 02 (9:00 a.m. – 5:00 p.m. CDT)

Verification and validation of analytical methods

  • Protocols
  • Trials
  • Documentation

Management and control of laboratory instruments

  • Qualification
  • Calibration
  • Maintenance

Management and control of laboratory supplies

  • Standards
  • Reagents, chemicals

Good conduct of laboratory investigations

  • Results out of specification
  • Outstanding results
  • Root cause analysis
  • Documentation

Consequences of laboratory non-compliance

For more information on this training visit https://www.researchandmarkets.com/r/bqnsbi

Media Contact:

Research and Markets
Laura Woodsenior
[email protected]

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SOURCE Research and Markets

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