Course Description
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.
Speaker:
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.
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? Audience
Facilities
MicrobiologyProfessionals
QualityAssurancepersonnel
QualityControlpersonnel
RegulatoryAffairsProfessionals
Research&Development
Validation
Auditors