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What is the ISO 13485?
What is the ISO 17025?
What is method validation?
Verification of compendial methods
Method transfers - good to know
Procedure and requirements for method transfers
Planning phase – Preparing a method transfer
Types of transfer and transfer strategy
Content of a transfer plan
Acceptance criteria of comparative method transfers
Filter validation: Good to know
Filter validation: Aspects to be considered
Filter validation: Information from the filter supplier
Filter validation: Product-specific studies that need to be performed by the filter user
Filter integrity tests – principles and influencing variables
The bacterial retention test according to ASTM F838-15-a
HPLC troubleshooting and method optimization
Examples for technical scientific documents
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