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New
NEW – Analytical Methods development ICH Q14 REVISED – Methods Validation ICH Q2 R1 AND review all the ICH Quality Guidances
- Do you work in analytical R&D developing methods?
- Do you perform methods transfer?
- Methods qualification?
- Methods validation?
- Did you know ICH Q2 R1 Methods Validation has been issued after major revision?
Have a question? We have the answer
Issues to be covered
Review of ICH as an organisation:
- Objectives of ICH
- Regulatory standing of the organisation
- Overview of their methodology:
E/Q/S/M modules
Review of the Quality Guidelines
- Q1 Stability Testing
- Q2 Analytical Methods Validation
- Q3 Impurities
- Q4 Pharmacopeial harmonization
- Q5 Viral Safety Evaluation – Biotech Products
- Q6 Specifications: Test Procedures and Acceptance Criteria
- Q7 GMPs for Active Pharmaceutical Ingredients
- Q8 Pharmaceutical Development
- Q9 Risk Management
- Q10 Pharmaceutical Quality System
- Q11 Development and Manufacture of Drug Substance
- Q12 Lifecycle Management of Products
- Q13 Continuous Manufacturing
- Q14 Analytical Methods Development
Who should attend
The course is suitable for anyone involved in R&D, contract laboratory services (provider or user) quality control, quality assurance, regulatory affairs, and any other discipline that interfaces with manufacturing and control of pharmaceutical development or production.
Benefits to the Participants
At the end of this course participants will have increased their awareness of ICH as a critical standard setting organisation in the regulatory world. The course will provide the opportunity to refresh and renew knowledge of ICH’s critical quality guidelines especially as they relate to methods development, transfer, qualification and validation.
About The Lecturer
Karen Taylor (Ginsbury)
Karen Ginsbury, CEO of PCI Pharmaceutical Consulting Israel Ltd. Karen
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