GAMPlification: Life sciences validation and GAMP training syllabus

Training goals

Participants will learn the basic concepts, principles, and terminology for qualification and validation activities utilizing guidelines of Good Automated Manufacturing Practice (GAMP). The participants are given the opportunity to use this knowledge to successfully execute an Installation Qualification (IQ) protocol, Operational Qualification (OQ) protocol, and Performance Qualification (PQ) protocol on a putting green during a 2-day course.

Prerequisite

Prior to attending the training session, attendees are required to take the RoviSys Continuing Education basic level GAMP courses. These courses are intended to give a basic introduction to validation and allow the attendee to utilize RoviSys’ proprietary file sharing software, GrandView.

Items discussed or performed during the training:

Day 1

• Introduction to RoviSys and instructor

• What is “validation”?

• Specifications in the GAMP life cycle – URS, FS, design

• Qualification protocols – IQ, OQ, PQ

• Procedures for testing in GAMP

• Introduction to the putting system

• Performing an Installation Qualification on the putting system

• Review/critique executed IQ’s

Day 2

• Performing an Operational Qualification on the putting system

• Review/critique executed OQ’s

• Performing a Performance Qualification on the putting system

• Review/critique executed PQ’s

• Maintaining a validated state

• Q & A

Expert training is available at both RoviSys offices, located in Aurora, Ohio, and Apex, North Carolina or at the customer’s facility. Entire teams or departments can be trained at one time. Training sessions are customized to include your specific needs and requirements and to meet your work schedules. The above syllabus is intended to give an overview of the basic principles necessary to achieve an understanding of validation, by using a fun and interactive approach. To schedule your training session or ask additional questions, contact John Turk or Scott Fischer.