This webinar will explain ICH and USP guidelines for validation and how to apply ICH guidelines for method transfer and how to establish boundaries.
It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at the drug development stage, rather than during routine manufacture, will improve the overall success of the project. Attend this webinar to understand the ICH and USP guidance for validation, and how to apply ICH guidelines for method transfer and how to establish boundaries.
Why Should You Attend:
Once a product goes commercial, measuring the quality, safety, and efficacy attributes of the drug substance and the drug product is crucial. There are well-established ICH guidelines for the validation requirements of typical analytical procedures. In contrast, the requirements for a technical transfer of an analytical procedure from one site to another or within a site to a separate facility are often debated.It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at the drug development stage, rather than during routine manufacture, will improve the overall success of the project. Attend this webinar to understand the ICH and USP guidance for validation, and how to apply ICH guidelines for method transfer and how to establish boundaries.
Areas Covered in the Webinar:
- ICH guidelines for validation.
- USP guidelines for validation and verification.
- Applications of the ICH guidelines for method transfer.
- Debated topics and approaches.
- Complex procedures.
- Establishing boundaries.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:- QC functions in general
- QC technical transfer groups
- QC validation groups
- Commercial testing facilities
- Product development
- Commercial project support
Course Provider
Barbara Berglund,
