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2020 - Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Date2020-03-02 - 2020-03-03


VenueSouth Easton, MA, USA - United States USA - United States

KeywordsEU Annex 15; Q9 Quality Risk Management; Analytical Methodology


Topics/Call fo Papers

Why these FDA Guidance/EU Guidelines for Industry - Process Validation is so important to the pharmaceutical and biotechnology industry.
What FDA segments are included and excluded within the "NEW" Process Validation.
Where does the Process Validation commence.
What are the Three Stages and Where DThey Apply within the NEW Process Validation.
How Stage 1 integrates with Phase 1.
The Validation approaches that are included within this Guidance document.
The Statutory and Regulatory Requirements for Process Validation.
An Introduction tPhase 1 Guidance for Industry and Its Application within the "NEW" Process Validation.
The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required.
General Considerations for Process Validation - Stage 2 Process Qualification.
Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2.
General Considerations for Process Validation - Stage 3 Continued Process Verification.
A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance.

Last modified: 2020-01-14 14:36:57