GMP/GDP Updates
including recent updates

Lecturer: Ms. Karen Ginsbury

Date: 27 November 2019
Location: Kfar Maccabiah, Ramat Gan
Category: Quality
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,950 NIS+VAT
Credit Points: 1
SKU: 19264
Course Language: Hebrew
About the Course
The workshop will address the following regulations and guidances in their current, recently revised, draft or concept paper formats:
  • Revised FDA Quality Metrics Draft Guidance
  • FDA FINALIZED Quality Agreements Guidance
  • FDA Draft Supply Chain Guidance
  • EMA Q&A on GMP
  • GMP/GDP IWG 2018 program
  • EU GMPs Overview with focus on:
    • Management review
    • Risk Management (practical implementation)
    • PQR
    • Internal audits
    • Effective investigations
    • GDP for APIs
  • EU Risk based assessment on GMP for excipients
  • US GMPs: 21CFR parts 210, 211, part 11 and part 820
  • FDA guidance Workplan for 2018
  • Data Integrity
  • WHO Guidances
  • PIC/s Guidances
  • USP, European Pharmacopoeia
  • Pulling together the threads and staying updated
Who should attend
This course is suitable for:
Anyone working in the pharmaceutical industry including Company General Managers, Managing Directors (GMPs and ICH Q10 focusing on management leadership), QPs, Quality Assurance, Quality Control and other quality professionals, Operations and Production managers, Research and Development, persons working in technology transfer, personnel working in pharmaceutical Active substance and finished product manufacture as well as distributors, brokers, wholesale dealers and anyone involved in the manufacture of starting materials, Active Substances, finished pharmaceuticals or involved in the handling, processing or sale or administration of any of these.  Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course very useful.
GMP/GDP Updates
including recent updates
Benefits to the Participants
Participants will come away from this course with a list of sources for GMP updates and a rapid overview of the changes that have been recently implemented as well as those currently under consideration / comment.  A refreshing and novel outlook at the slightly drooping quality system.  Opportunity to benchmark with colleagues – am I doing it right?
Contact us
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Issues to be covered

Note: This course will meet your requirement for annual GMP training.  Stay up to date.  Did you know about these new guidances?

Drafts or finalized guidances HOT OFF THE PRESS:

  • EU GMP for Investigational Product (IMPs)
  • The use of statistical methods to show comparability of Critical Quality Attributes in the lifecycle of a product
  • FDA Draft Supply Chain Guidance
  • Data Integrity guidances
  • EMA and FDA Questions and Answers on GMP

Objective: Provide a rapid update of GMP related regulations and their ongoing interpretation.  This interactive workshop will allow participants to gain a new perspective on old topics as well as figuring out what the regulator is focusing on and where the next surprise might be!

About The Lecturer

Ms. Karen Ginsbury

Karen Ginsbury is a London, UK trained pharmacist with a second degree and passion for microbiology. With hands-on experience of cleanroom management, Karen has over 27 years of experience in the pharmaceutical industry working at setting up, implementing and continuously improving quality systems. Karen is an experienced risk management facilitator as well as a lively and highly interactive lecturer.
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