עדכוני GMP/GDPincluding recent updates

בהדרכת: גב' קרן גינסבורי
גרסה להדפסה

שתף קולגה:

מקוון - בזום
הישארו מעודכנים ועיבדו בראש אחד עם הרגולטור בארה"ב ובאירופה
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  • Revised FDA Quality Metrics Draft Guidance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...המשך קריאה

הישארו מעודכנים ועיבדו בראש אחד עם הרגולטור בארה”ב ובאירופה

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  • Revised FDA Quality Metrics Draft Guidance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
סגור
תאריכים: 
  • 03/11/2020
  • 04/11/2020
מיקום הקורס: הקורס יועבר באמצעות Zoom
משך הפעילות: 2 חצאי יום לימוד (בוקר)
שעות: 13:30 - 10:00
נקודות זכות: 1
שפת הקורס: עברית

עלות הקורס: 1,700 ₪ + מע"מ
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מה תכני הקורס?

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!

למי זה מתאים?

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.

מה אקבל מכך בפועל?

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?

מי מעביר את הקורס?

קרן גינסבורי
קרן גינסבורי, M. Sc. B. Pharm. MR PharmS – בעלת
קרא עוד

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