Tuesday March 27, 2018
10:00 am – 11:30 am EDT
Instructor: Barry A. Friedman, Ph.D., LLC (more about the Instructor)
Whether a Company is developing a new product or facility, the issue of a comprehensive Validation Package is essential to assure the timely completion of all activities. A Validation Package is designed to satisfy both current domestic and international regulations, guidelines and policies for active pharmaceutical ingredients (APIs), drugs, biologics and devices and to verify equipment systems, utilities, software and processes are properly designed (DQ), installed (IQ), operate (OQ) and perform (PQ) in a consistent and controlled manner.
The purpose of validation is to assure the facility, manufacturing process, and supporting services are capable of supporting the manufacture of pharmaceutical and device products that consistently meet their predetermined quality attributes. The Validation Master Plan (VMP) uses a “life cycle” approach and emphasizes Risk Management (ICH Q9) as the Plan proceeds from validation through verification and qualification. The VMP is intended to project a picture of how your company has integrated current Good Manufacturing Processes (cGMP) as promulgated in 21 CFR Part 820 and 211, into all aspects of the manufacturing process. The Validation Program is designed to proactively assure GMP compliance from facility development through the distribution of final product.
The Site Validation Master Plan applies to all validations as well as qualification and verification activities within a Company. It represents a policy document that references individual validation programs. Validation packages come in all “flavors”, but some of those that are more popular include:
- Process Validation (Stage 1, 2 and 3)
- Facilities validation to include: a) HVAC, b) Water systems, c) Equipment placement and installation
- Facilities validation with emphasis on sterilization to include: a) Steam, b) Dry Heat, c) Filtration
- Cleaning and Disinfection validations
- Analytical to include: a) Chemistry, b) Microbiology
- Packaging
- Computer to include: 21 CFR Part 11
By attending, you will learn: - Validation Plans are not Optional
- Why a Company must possess a Master Validation Plan
- How did Validation Plans originate
- The purpose and scope of a comprehensive Master Validation Plan
- To identify those responsible for the Master Validation Plan
- To identify the sections required within a Master Validation Plan
- To learn of the requirements within each individual Validation “type” within a Master Validation Plan
- Why emphasis on “Process Validation” in today’s environmentFee:$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
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