GMP/GDP UpdatesIncluding recent updates

Conducted by: Ms. Karen Ginsbury
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This Refresher will meet your requirement for annual GMP training!

ON THE MENU:

  • What’s hot:
    • recent inspection findings
    • Review and discuss US FDA 483 and warning letter findings
  • Updates to:
    • EU GMPs and annexes, guidelines
    • US GMPs and guidances
    • ICH
    • PIC/s
    • WHO
    • Pharmacopeias
  • Want to know what’s happening in the...Continue reading

This Refresher will meet your requirement for annual GMP training!

ON THE MENU:

  • What’s hot:
    • recent inspection findings
    • Review and discuss US FDA 483 and warning letter findings
  • Updates to:
    • EU GMPs and annexes, guidelines
    • US GMPs and guidances
    • ICH
    • PIC/s
    • WHO
    • Pharmacopeias
  • Want to know what’s happening in the pharmaceutical industry? You better attend
  • Has your QMS health improved since 2023 – benchmark with colleagues and Karen and decide.
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Date:  22 May, 2024

מתעניינים? לחצו כאן

    Course location: Hybrid: Kiryat Weizmann Ness Ziona or ZOOM
    Duration: 1-Day Course
    Hours: 09:00 - 17:00
    Credits: 1
    Course Language: עברית

    Course price: ₪2,300 + VAT
    Early registration is Closed
    Do you have a subscription? You deserve more

    Have a question? We got all the answers

    Issues to be covered

    Included in the GMP updates:

    1. Identification tests of starting material and reduced monograph testing
      allowed? Or not?
    2. Process monitoring and batch release – statistical process control?
    3. ICHQ3C Residual solvents update – just issued
    4. PIC/s updates: vision of one inspection which satisfies all global regulators (FDA, EU, Japan etc.)
    5. Implementation of Annex 1: Sterile Product manufacture and the Contamination Control Strategy
    6. Inspection efforts – EU GMP/GDP Inspectors workplan for 2024 – 2026:
      – Enhance supply chain traceability, oversight and security
      – Guidance reinforcing responsibility for product quality:EU level data integrity guidance
      together with WHO and PIC/s
      – Revisions to Chapter 4 of the GMPs: Documentation
      – Revised Annex 11: Computerised Systems
      – Revise ATMP GMPs
      – Revised Annex 15: Qualification and Validation addressing new technologies (AI and ML)
      – ICH Q12 Lifecycle management integration into inspections
      – PIC/s – ICH MOU and increased cooperation / enforcement of ICH guidance?

    The course will address all of the checkboxes above and more and will pull together the threads to allow you to understand where to focus limited resources for maximum return on investment

    Objective:

    Provide a rapid update of GMP regulations, their ongoing development and interpretation. This course will allow participants to gain a new perspective on old topics and figure out what the inspector is focusing on and where the next surprise might be.

     

    Who should attend

    This course is suitable for:

    Anyone working in the pharmaceutical industry including:

    • Company General Managers
    • Managing Directors (effective quality systems focus on executive management actively leading the system)
    • Hospital pharmacists & QPs
    • Quality Assurance, Quality Control and other quality professionals
    • Operations Managers
    • Production Managers
    • Research and Development (R&D)
    • persons working in technology transfer, pharmaceutical Active Substance and finished product manufacture as well as distributors, brokers, wholesale dealers
    • Anyone involved in the handling, processing or sales or administration of any of these
    • Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course useful

    Benefits to the Participants

    Participants will come away with a list of sources for GMP updates and a rapid overview of the changes that have been recently implemented and those under consideration / comment.

    About The Lecturer

    Karen Ginsbury
    B.Pharm, M.Sc, MRPharmS, has over twenty five years of experience
    Read more
    תחזוקת מערכת האיכות בזמן מלחמה QMS

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