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).

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
Process Validation Guidance Requirements
(FDA and EU Annex 15: Qualification and Validation)
Los Angeles, CA
July 28th & 29th, 2016
9:00 AM to 6:00 PM
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.
Global
CompliancePanel
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.
(Without Stay) Price: $1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price

2. Global
CompliancePanel
AGENDA:
Day One Day Two
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
Lecture10: Regulatory Strategies for Phase 2 and 3 and
their Incorporation within Stages 1 and 2
Lecture 11: Questions?
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.
2-day In-person Seminar:
Process Validation Guidance Requirements
(FDA and EU Annex 15: Qualification and Validation)
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?

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CompliancePanel
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2-day In-person Seminar:
Process Validation Guidance Requirements
(FDA and EU Annex 15: Qualification and Validation)