This FIVE-HOUR 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.
Learning Objectives - FDA Process Validation Training
By the end of this training, participants will be able to:
- Understand why FDA Guidance and EU Guidelines on Process Validation are critical to the pharmaceutical and biopharmaceutical industry.
- Identify where process validation begins and how it evolves throughout the product lifecycle.
- Recognize how Stage 1 (Process Design) aligns with Phase 1 (Clinical Development).
- Learn which FDA sections are included and excluded in the “New” Process Validation framework.
- Explore the three stages of process validation and their applications within the updated guidance.
- Gain knowledge of validation and verification approaches outlined in the FDA guidance document.
- Review the legal and regulatory requirements for process validation and procedure approval.
- Examine Phase 1 guidance for industry and its application within the “New” Process Validation.
- Clarify the requirements and exemptions for investigational (Phase 1) drugs.
- Apply general considerations for Stage 2 (Process Qualification) in practical scenarios.
- Understand regulatory strategies for Phase 2 and Phase 3 and how they connect to Stages 1 and 2.
- Review general considerations for Stage 3 (Continued Process Verification) to ensure long-term compliance.
- Compare EU Annex 15 requirements with FDA’s Process Validation guidance to identify similarities and differences.
Course Content
DAY 01 Agenda
- 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 Agenda
- 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?
Course Provider
Dr Barry A. Friedman, Ph.D,
Consultant ,
Cambrex Bio SciencesDr. 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.
Who Should Attend
The following professionals will gain significant value from FDA Process Validation Training:
- Quality Control (QC) Professionals
- Project Managers
- Quality Assurance (QA) Specialists
- Product Development Teams
- Regulatory Compliance Professionals
- Industrial and Facilities Specialists involved in process validation and compliance activities
- Professionals seeking to enhance their knowledge of the challenges and requirements related to method validation and endorsement
