Quality Control Laboratory Compliance – cGMPs and GLPs – 6 Hours Virtual Seminar

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Good Laboratory Practices (GLPs), 21 CFR part 58 is a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

GLPs are not enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

GMPs, Good Manufacturing Practices, 21 CFR part 210 and 211, is a set of guidelines for the actual manufacturing and packaging of finished products. The GMPs are enforceable by law. During this course GLPs and GMPs will be compared and contrasted. The differences and similarities will be discussed. The attendees will gain a better understanding of how these guidelines work together and enable the finial production of quality products.

Course Objective:

  • During this webinar participants will learn what GLPs and GMP are, how they are similar and how they are different. They will learn how and why both these regulations were created, a brief history of each will be given.
  • Participants will have a better understanding of the importance of these regulations and how they work together to enable production of the highest quality products.
  • Participants will also gain an understanding of the consequences of noncompliance such as disqualification and reinstatement.

FDB2480

Joy McElroy

Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

Session 1

Understanding FDA law and regulations for QC laboratories

 

  • What is adulteration?
    • Pharmaceuticals
    • Biologics
    • Medical Devices
  • What is CGMP?
    • Pharmaceuticals
    • Biologics
    • Medical Devices
  • What is GLP?
    • Contract Laboratories
    • FDA inspection methodology
  • Laboratory Organization
    • Organization
    • Personnel qualification and training

Session 2

Documentation

 

  • Documentation and record-keeping requirements
    • Standard Operating Procedures
    • Analytical Methods
    • Raw data (notebooks, print-outs)
    • Document management (change control, retention)
    • Part 11 (electronic records and signatures)
  • Sample integrity requirements
    • Sample collection
    • Sample delivery, handling, disposition
    • Retain samples
  • Stability (shelf-life) studies
    • Organization and management
    • Storage units
    • Analytical methodology
  • Analytical methods verification and validation
    • Protocols
    • Tests
    • Documentation

Session 3

Management and Control

 

  • Management and control of laboratory instruments
    • Qualification
    • Calibration
    • Maintenance
  • Management and control of laboratory supplies
    • Standards
    • Reagents, chemicals
  • Proper conduct of laboratory investigations
    • Out-of-specification results
    • Root cause analysis
    • Documentation
  • Proper conduct of laboratory investigations

Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Research and Development Personnel
  • Regulatory Affairs Personnel
  • Project Managers
  • Manufacturing Managers
  • Validation Engineers
  • Internal Auditing Personnel
  • Microbiology Personnel
  • Auditors

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.