Cleaning Validation Seminar for the Pharmaceuticals Industry
Quality Assurance
Engineering & Validation
Starts at: 09:00
Duration: 1 Meeting
Language: Hebrew
The seminar will review the regulatory requirements and guidelines of the cleaning validation lifecycle.
In the seminar, we will learn about examples of authorities' observations, how to avoid common mistakes, and practice.
The topics of the seminar:
-Details of the regulatory requirements
-The lifecycle of cleanliness verification
-How to calculate the cleaning limits
-Risk management for worst-case selection
-Validation of the analytical method
-Microbiological considerations in cleaning
-Validation of the cleanliness of biotechnological products
-Examples of comments from regulatory authorities
-How to avoid common mistakes
-Case study practice
Seminar date - 10.11.26
Seminar Hours - 09:00-17:00
About Iris Shamir, M.Sc.
Former GMP inspector at the Pharmaceutical Inspection Division of the Israeli Ministry of Health’s Institute for Standardization and Control (ISCP). She served as a lead inspector in audits of laboratories, active pharmaceutical ingredient (API) manufacturers, dry production, semi-solid and liquid dosage forms, as well as wholesalers and importers.Iris participated as an inspector in audits of aseptic and sterile processes, biotechnological...
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