Validation of laboratory systems, manufacturing facilities, manufacturing equipment, computer systems and analytical test methods may be nice to have in some businesses, but is an essential regulatory requirement for regulated companies.
This workshop is designed to give attendees basic training in the principles and practices of validation, using your own systems as examples in our workshops of what to do, what not to do and how to document validation for inspection.
In this two day workshop conference:
- You will learn the different global agencies expectations of validation for pharmaceutical manufacturers or contract organizations supporting GMP/GLP/GCP operations
- We will focus primarily on drugs and devices, and will tailor the course to the specific needs of the attendees using case studies from both our own and attendees experience (within limits of confidentiality)
- You will earn the underlying regulations and the current industry practices for risk-based validation, with take-away lessons and learning you can apply to be more efficient and effective back on the job
- We will make available workshop materials including templates for various types of validations, and complete several in-session using real-life working examples
- We will facilitate both public and private review sessions where confidentiality must be maintained
- Upon registration attendees will receive some advance conference materials to gather information to use in their own workshop and private sessions.
Upon completing this course participants should:
- Know the domestic and foreign regulations requiring validation
- Understand the principles of validation
- Be able to design a risk-based validation plan which can significantly reduce validation effort and documentation
- Understand the relationship between specifications and verifications
- Know which validation documents are critical for inspection
- Design a validation plan and qualification protocols for their own systems
- Be able to effectively present validation documentation for inspection
Who will Benefit:
This course is designed for people responsible for the validation of equipment, facilities, computer systems and test methods used in GMP facilities. This includes the end users, scientists, chemists, engineers, quality assurance and system administrators working in drug, device, pharmaceutical companies, as well as their counterparts in contract research, contract manufacturing and contract analytical testing organizations.
Following personnel will benefit from the course:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
- Quality Control chemists