| Who Should Attend: Attendance will be beneficial to all personnel directly involved in process validation, as well as, new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with the above or interact with regulatory agency inspectors to rationalise or defend validation programs will also benefit from attending this course.
Process validation is not a curse, invented by regulators, pushed onto a company by QA staff. Process validation is a legal requirement in the pharmaceutical industry. Regulatory agencies will not approve your product without it. The concept of process validation is recognition that quality cannot be tested into the product.
In most cases, a branch within the “Quality” organisation of the firm handles coordinating and documenting compliance with this requirement, and the concept still evokes undertones of mystery and the unknown to some engineers and scientists from other disciplines within “Operations”. However, the fact is that operational personnel will most likely have to interact with the group responsible for the execution of the process validation efforts sooner or later. This course provides practical guidance on compliance with the requirements of process validation that leads to risk-based, reasonable and supportable informed decisions and planned activities. Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.
The course includes process validation examples from pharmaceutical and medical device manufacturing processes.
Course Contents:
Using a series of formal presentations, combined with various practical exercises and case studies, the workshop is designed to be interactive, and so promote understanding of validation, with focus on Process Validation.
Introduction
Business Benefits of Process Validation
Regulatory Requirements & Guidelines
Validation Master Plan
Validation versus Verification
Statistical Methods & Tools for Validation
ISO 14971 & Risk Assessment
Equipment Qualification
Cleaning Validation
Product & Process Validation
21 CFR Part 11 – Electronic Signatures & Records
Case study & exercise
Preparing a Validation Master Plan
Preparing a Process Validation Protocol
Preparing a Process Validation Report
Maintaining a state of validation
Retrospective Validation
Review of recent FDA Warning Letters
Note: The above syllabus may change during the training course to provide more detail in aspects, which have been ascertained to be of greater value to the trainee. |
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