Seminar on Process Validation 2016 - Seminar on Process Validation

Course "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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. The 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 two day Seminar 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? 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.
Why should you attend:
The Process Validation Guidance for Industry was recently revised after many years. With the emphasis today on being able to assure that a process is meeting its requirements through Validation, and not simply through Verification or Qualification, an understanding of both its importance and how to accomplish this feat has come to the fore. In addition, with ICH Q9, Risk Management, involved in every aspect of our day to day operations, it becomes especially important to learn how this meshes with Process Validation. The FDA and especially CDER, with their new auditing format, will be wanting to understand how each Company performed their Validations in all areas to include manufacturing and Quality. Having an enhanced understanding of the Process Validation Guidance will assure that your firm is meeting the FDA's current requirements.
Areas Covered in the Session:
? 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.
? A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance.
Who will benefit:
? Facilities
? Microbiology Professionals
? Quality Assurance personnel
? Quality Control personnel
? Regulatory Affairs Professionals
? Research & Development
? Validation
? Auditors
Agenda:
Day 1 Schedule
Lecture 1: Introduction; Goals and Objectives; Definitions,
Lecture 2: Process Validation - Its Importance within the Drug Industry,
Lecture 3: Interaction of the Three Stages with Process Validation,
Lecture 4: Changes with the Commencement of Process Validation,
Lecture 5: Validation Approaches,
Lecture 6: cGMPs in Clinical Supply Manufacture,
Lecture 7: Special Manufacturing Situations within Phase 1
Lecture 8: The Requirements for "Safe" Product within Stage 1,
Lecture 9: The Requirements of Phase 1 Investigational Drug Requirement,
Lecture 10: Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2
Lecture 11: Questions?
Day 2 Schedule
Lecture 1: General Considerations for Process Validation - Stage 2 Process Qualification,
Lecture 2: Special Considerations for Process Validation - Stage 2,
Lecture 3: General Considerations for Process Validation - Stage 3 Continued Process Verification,
Lecture 4: A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance
Lecture 5: Concurrent Release of Process performance Qualification (PPQ) Batches,
Lecture 6: Analytical Methodology and Process Validation,
Lecture 7: Warning Letters Related to Process Validation
Lecture 8: Questions?
Speaker:
Barry A Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, 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 compliance interactions.
Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology. In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.
Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter ?dissection?, multi-departmental interactions, 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, TungstenShield, IPA (Canada) and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 180 Blogs that address various Warning Letter and FDA 483 issues. He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.
Location: Los Angeles, CA Date: July 28th & 29th, 2016 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Hotel Los Angeles Downtown
Address: 120 South Los Angeles Street, Los Angeles, California, 90012, USA
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until June 10, Early Bird Price: $1,295.00 from June 11 to July 26, Regular Price: $1,495.00
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Registration Link - http://bit.ly/Process-Validation-Guidance
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