Process Validation Workshop

Process Validation Workshop Dates: December 15 & 16, 2008 Cost: non-members $1,095 members $895	Member Cost $895.00 Date Attending: September 29 & 30, 2008 October 21 & 22, 2008 December 15 & 16, 2008
	Non-Member Cost $1,095.00 Date Attending: September 29 & 30, 2008 October 21 & 22, 2008 December 15 & 16, 2008

Process Validation Principles and Protocols

Description
Using careful reviews of requirements from ISO 9001:2000, ISO 13485 and QSR along with case studies and in-class activities, learn the fundamentals and principles of process validation. Focus is on the planning, specifications, and requirements necessary to meet ISO and FDA requirements for process validation. FDA defines process validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.”
Process validation class discussions and team workshops also cover interpretation of process validation as described by the Global Harmonization Task Force and as required by FDA’s Medical Device Quality System Regulation, ISO 9001, ISO 13485:2003.

Topics for this course include:
Key definitions and terms
Principles and protocols
Process validation Special process recognition
Facilities validation
Utilities and equipment
Process capability design and qualification
Validation program
Objectives
Understand the purpose, benefits and objectives of process validation
Discuss ISO and FDA requirements for process validation as an integrated model
Recognize planning and resource requirements
Understand integration of computer systems controls into operations and facilities validations
Describe the concepts of prospective, retrospective validation, and revalidation
Understand performance qualification and equipment qualification, installation qualification, and operational qualification
Differentiate between equipment, process, and product
Understand validation techniques: organizing teams, process characterization, and process flowcharts
Explain validation parameters: operating and process conditions, test methods, results analysis, acceptance criteria, limits testing, and computer control
Follow validation protocols: guidelines, format, and presentation
Establish records documentation requirements

Target Audience:
Recommended for mid-level technical management, manufacturing engineering, facilities, production management, and quality assurance professionals involved in planning, executing, reporting, and maintaining manufacturing process validation.

QSG University's workshops are designed for and intended to serve individuals using and relying upon QSG services. QSG University reserves the right to limit workshop attendance strictly to the foregoing. In addition, QSG University reserves the right to change, reschedule or cancel any workshop at any time.