FDA Process Validation Training Description

This FIVE HOUR/DAY FDA Process Validation Training session is an interactive ON-LINE 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



Training Agenda – from Course Instructor

DAY 01 (09:30 AM to 01:00 PM)

Time of starting the session: 09.30 AM

▪         Overview, Goals and Objectives, Definitions.

▪         Process Validation - Its Importance within the Drug Industry

▪         What is included in the “New” Process Validation (PV) Guidance?

▪         The Constitutional and Supervisory Requirements for “PV”

▪         Interaction of the Three Stages with Procedure Validation

▪         General Considerations for ‘PV” – Stage 1

▪         Stage 2 – Phase 1. History and Controlling Basis

▪         Authentication Methods, cGMPs in Scientific Supply Manufacture,

▪         What’s Included within Phase 1, Stage 2

▪         A Review of Industrial Deliberations

▪         Special Industrial Situations within Phase 1

▪         Multi-Product Amenities and their Organization

▪         Management of Organic and Biotechnology Amenities

▪         Management of Sterile Products/Aseptically Produced Products

▪         The Necessities of Phase 1 Investigational Medication Necessities

▪         How does One Understand and Utilize Them?

▪         Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2

▪         Operation of Procedure Design to Regulate its Duplicability Competences

. Organization of Amenities, Apparatus, and Values Requirement

DAY 02 (09:30 AM to 01:00 PM)

▪         General Deliberations for Procedure Authentication – Stage 2 Process Qualifications

▪         Requirement of Values and Gear

▪         Expansion of Ecological or Conservational Monitoring

▪         Development of Amenities Project

▪         Water Systems Development

▪         Special Deliberations for Procedure Authentication – Stage 2

▪         Appraisal of Special Study Protocols

▪         Studying the Special Requirements of Phase 2/3 Stage 2

▪         Overall Considerations for Process Validation – Stage 3 Sustained Process Corroboration

▪         Promising Continued Process Confirmation Remains in Control

▪         Use of Cautionary Letters as Instances

▪         A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance

▪         A Demonstration of Similarity Between the Two

▪         Simultaneous Issue of Process Presentation Qualification (PPQ) Batches

▪         Rationalizes Why it Requires being Accompanied by a Systematic Critical Overview

▪         Must be evaluated for Stability Program Inclusion

▪         Analytical Methodology and Process Validation

▪         Discusses the Need for Accurate and Precise Monitoring Techniques

▪         Why are the Development Validated Methods necessary? 



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

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.



Who are the probable beneficiaries?

The following people are supposed to be the clear beneficiaries of FDA Process Validation Training:

▪         Quality Control

▪         Project Management

▪         Quality Assurance

▪         Product Development

▪         Regulatory Compliance

▪         Product Development

▪         Industrial and Amenities specialists who need to grow and participate in developing understanding regarding the issues surrounding Method Endorsement.



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Faculty Barry A. Friedman

Barry A. Friedman, Ph.D (30+ Year Exp.)

Ph.D. at The Ohio State University

Sarasota, Florida

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, GLP/GMP, quality control, auditing, microbiology consulting, expert witness, 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. He was responsible for the microbiology, environmental monitoring and analytical chemistry for Phase 1, 2, 3 and commercial products aseptically filled/lyophilized.


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 The Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from The Ohio State University in Microbiology