GMP/GDP Updatesincluding recent updates

Conducted by: Ms. Karen Ginsbury
Categories: Quality
SKU: 20264
Print version

Share a colleague:

Online - zoom
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  • Revised FDA Quality Metrics Draft Guidance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
    • ...Continue reading

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  • Revised FDA Quality Metrics Draft Guidance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
Close
Dates: 
  • 03/11/2020
  • 04/11/2020
Course location: Zoom Course
Duration: 2 half-day Course (Morning)
Hours: 10:00 - 13:30
Credits: 1
Course Language: עברית

Course price: 1,850 NIS + VAT
Do you have a subscription? You deserve more

Have a question? We got all the answers

Issues to be covered

The syllabus will address recent updates including the upcoming EU Annex 21 on Good Importation Practices and the draft Israeli Ministry of Health SOP on  GDP for finished product and for APIs

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!

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.

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?

About The Lecturer

Karen Ginsbury
B.Pharm, M.Sc, MRPharmS, has over twenty years of experience in
Read more

Leave a Reply