Process & Cleaning Validation

William G. Marshall

All personnel involved with implementation, management, training, monitoring auditing in the areas of pharmaceutical production. This course will benefit those who are faced with task of validating or who are responsible for compliance with the associated regulatory requirements, or who are involved with manufacturing pharmaceutical products, medical device products, conductors and people providing equipment to the pharmaceutical and medical device industry.

By the end of this course you will have received a balanced blend of theoretical and practical information pertinent to process and cleaning validation of pharmaceutical and allied industries.
Upon completion of this course, you will have gained an understanding of the various concepts and philosophy of process and cleaning validation, and you will be able to apply the principles to your own operations and know how to choose relevant statistical tools and techniques for validation of pharmaceutical processes.
Namely, you will get to know key issues and common problems encountered in the preparation of Validation Documentation for the FDA, the various current and advance formulation approaches fostering an appreciation of the distinctive requirements of both dosage forms and acquaintance with quality control procedures and international regulations; contracts and similarities will be carefully drawn between U.S. and EU regulatory approaches, using validation guidelines and other pertinent information.

Course Outline
Process Validation
• Overview of validation principles:
o The organization - who generally performs the validation functions and who do they report to?
o The key parts of the validation system (The master plan, URS, DFQ, FAT, commissioning, IQ, OQ, PQ, Review and approval)
• Retrospective validation approaches
• Using analysis to allocate recourses
• Case study
• Categories of validation
o Process validation
o Analytical method validation
o Utilities validation - steam, water, gases, HVAC etc
o Software validation
o Cleaning validation - brief overview. Cleaning validation will be discussed in greater detail in cleaning validation session.
• Case studies and discussion of each type of validation from URS to PQ
• The vendors role in supporting the IQ and OQ
• Discussion and wrap up
Cleaning Validation
• The cleaning validation master plan
• Listing the cleaning processes
• Pragmatic risk bases ranking of manufacturing processes to identify what processes must be dedicated, what processes must be validated to a very low level of carryover
The HVAC system impact on active ingredient carryover
• Using the matrix system to consolidate validation projects
• How to set acceptable limits for carry over
• Case studies
• Discussion and wrap up

Course Description
IVEPE-SEV has developed a comprehensive 2-day seminar on validation with Mr. William G. Marshall, a well-known training specialist in pharmaceutical issues.

These courses will provide pragmatic, simple, step-by-step directions for establishing validation procedures in compliance with current practices for the pharmaceutical and allied industries.

The courses are welcoming questions, input and discussion; their general format is to involve everyone attending as much as possible in discussion of validation issues they are confronting. Attendees are invited to bring their issues, questions and case studies to be covered either during the course or in one on one session with Mr. Marshall. All pharmaceutical and allied personnel etc will benefit from this 2-day course.

English will be used in all lectures and course notes.
Because of the interactive structure of our courses, we have found that the provision of translation facilities is not effective.