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GMP/GDP Updatesincluding recent updates
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- Revised FDA Quality Metrics Draft Guidance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
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
