Wednesday April 10, 2019
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Whether a Company is developing a new product or facility, the issue of developing the key elements 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 Quality 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
The objective of this interactive Executive Conference Corp (ECC) webinar is to provide guidance throughout the development of a complete validation program to include Phases 1, 2, and 3 and understand why this FDA Guidance is not optional. Please consider attendance as a multi-disciplinary group to gain the most on this topic.
By attending you will learn:
- Why Validation Plans are not Optional
- Why a Company must possess a Master Validation Plan
- How did Validation Plans originate
- Statutory requirements within a Validation Plan
- The purpose and scope of a comprehensive Master Validation Plan
- To identify those responsible for the Master Validation Plan
- To identify the Phase information required within a Master Validation Plan
- Why emphasis on “Process Validation” in today’s manufacturing operations
Personnel who should consider attending include:
- Validation
- Manufacturing
- Engineering
- Quality Assurance
- Quality Control
- Metrology
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-101