Process Validation Guidance Requirements; FDA and the New EU Annex 15: Qualification and Validation Guidances
Live, Interactive Training Webinar
Available Live On-Demand
Barry A. Friedman Ph.D. Biography>>>
Available Live On-Demand
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, 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 lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management. These new Process Validation Guideline/Practice incorporate 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.
Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products. This interactive live webinar provides a conduit to enhance your understanding of the utilization of Process Validation and Phase 1, 2 and 3, where their Guidances blend and where they remain distinct. In particular, Stage 3 Continued Process Verification, will be reviewed in detail. Where does it begin; what is included; and, when does it end.
Common questions asked by the users of Process Validation include; how does one integrate these two different concepts (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Do they exist independently of each other or do they complement each other to enhance, build and provide a product that neither alone could. Questions that may arise include where are cGMPs initiated? To what extent must they be used? Since Stage 3 extends through commercial batch manufacturing, what happens to Phase 3? Does it follow along or with Stage 3. Other questions that exist include how one manages special situations to include viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests to include DNA and host cell protein. These questions will be addressed within Stage 2 as presented here.
Participants in this live training webinar learn about both the FDA Guidance for Industry Process Validation Requirements as well as the EU Guidelines Annex 15: Qualification and Validation, their integration and how this recently released EU document (October 2015) may impact your organization. Please plan to attend this as a team event to share this recent update.
- Why these FDA Guidance for Industry/EU Guidelines – 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 Do They 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 to Phase 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 1/2.
- General Considerations for Process Validation – Stage 3 Continued Process Verification.
Webinar outline and time breakdown:Time*
|9:15 AM||Log In Period|
|9:40 AM||Goals and Objectives,|
|Process Validation – Its Importance within the Drug Industry,|
|Interaction of the Three Stages with the Process Validation,|
|Changes within the Commencement of the Process Validations,|
|cGMPs in Clinical Supply Manufacture,|
|The Requirements of Phase 1 Investigational Drug Requirement,|
|10:40 AM||General and Special Considerations for Process Validation – Stage 2 Process Qualification,|
|General Considerations for Process Validation – Stage 3, Continued Process Verification,|
|Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1/2,|
|Concurrent Release of Process Performance Qualification (PPQ) Batches,|
|11:30 AM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar: Those who will benefit from this seminar include R&D, Validation, Regulatory Compliance, Quality Assurance, Quality Control, and Manufacturing professionals who are required to maintain standards of compliance consistent with the latest revisions of the cGMP as well as those that use contract manufacturing and contract testing facilities for their testing applications.
Schedule & Deliver this Live Training Webinar Privately to Your Group
Instructor: Barry A. Friedman Ph.D.
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>
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