הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)
עדכוני GMP/GDPincluding recent updates
- Back face to face at Kfar HaMaccabiah with Karen Ginsbury for the very LATEST in GMP/ GDP news, requirements and expectations
- Latest Inspection Findings, practical interpretation and what you need to do
- This Refresher Course will meet your requirement for annual GMP training
יש לך שאלה? יש לנו את כל התשובות
מה תכני הקורס?
- FDA CDRH / CBER: Computer Software Assurance for Production and Quality System Software Draft guidance
- EU Annex 1 Manufacture of Sterile Medicinal Products
- FDA Risk Management Plans to Mitigate the Potential for Drug Shortages
- Guidance for Industry Draft guidance
- FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance
- ICH Q2R1: Validation of Analytical Procedures Draft step 2
- ICH Q14: Analytical Procedure Development Draft step 2
- FDA DOCKET: Quality Metrics Reporting Program
- Open for comments for 90 days
- EU Annex 21: Importation of Medicinal Products
- Comes into effect 21 August 2022
- FDA Guidance on Microbiological Considerations for NON-Sterile Products
- Final version – a detailed and somewhat complex document – makes it essential to have a Microbial Control Strategy
- ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products
- Currently (as of writing this) open for public comment
In addition to the above:
- What’s hot: inspectional findings
- GDP Guideline tree
- What’s new at WHO, Pharmacopeias
- How’s your QMS health and Industry 4.0?
למי זה מתאים?
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, 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 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.
מה אקבל מכך בפועל?
Provide a rapid update of GMP related regulations, their ongoing development and interpretation. This interactive workshop 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.
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.
The course will provide a GMP/GDP refresher and will pull together the threads to allow you to understand where to focus limited resources for maximum return on investment.
מי מעביר את הקורס?
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