1 Day Online Process Validation Guidance Requirements Course: Focus on FDA and EU Annex 15: Qualifications and Validation

2023-12-15

临床1期高管变更

DUBLIN, Dec. 15, 2023 /PRNewswire/ -- The "Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Course" training has been added to

ResearchAndMarkets.com's offering.

This FDA Process Validation Training session is an interactive online Seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail: The training course includes all necessary information regarding where it begins; what it includes; and, when it ends.

The Process Validation Guidelines (January 2011) and the EU Annex 15: Requirement and Authentication (October 2015) outline the overall values and methods the two controlling bodies reflect suitable elements of process validation for the production of human and animal drugs and biological foodstuffs, including Active Pharmaceutical Ingredients (APIs).

This directive aligns Process Validation activities with a product life cycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.

The life cycle concept, new to these Guidance, links creation and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. This supervision also cares for process development and novelty through sound science and risk management.

The new Process Validation Guideline/Practice includes elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing

Some general questions asked by the users of FDA Process Validation Training

Here are a few common questions that the trainees attending the FDA Process Validation Training must ask to upgrade their initial knowledge:

How can one integrate these two different concepts (Phase-wise and stage-wise)?

Where do they merge?

Can they exist independently or can they complement each other to improve, figure, and deliver a product that neither alone could?

To what extent, the users must use them?

Does it follow along with Stage 3? Questions that exist include how one manages special situations including viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests including DNA and host cell protein.

The experts for FDA Process Validation Training will address these questions in Stage 2 as presented here. It will include the utilization of Procedure Validation and Phase 1, 2, and 3, where their Guidance mixture and where remain distinct. In particular, Stage 3.

Important: The seminar insists that the trainees attending the FDA Process Validation Training plan to bring a multidisciplinary cluster from your Establishment to get the most from this very important seminar

Objectives of Learning for FDA Process Validation Training:

Why are these FDA Guidance/EU Guidelines for Industry-Process Validation so significant to the pharmacological and ergonomics industry?

Where does the Process Validation commence?

How does Stage 1 integrate with Phase 1?

What FDA sections are composed and omitted within the "NEW" Process Validation?

What are the Three Stages and Where do They Apply within the NEW Process Validation?

The Authentication approaches are included within this Guidance document.

The Constitutional and Supervisory Requirements for Procedure Endorsement.

An Outline to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation.

The Phase 1 Untried 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.

An Appraisal of EU Annex 15 and its Comparison to FDA's Process Validation Direction.

Speakers:

Barry A. Friedman, Ph.D

Consultant

Cambrex Bio Sciences

Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

For more information about this training visit https://www.researchandmarkets.com/r/i441zl

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