Overview: A validation program must have three basic elements - policy/procedures, adequate training for execution and compliant/complete documentation. The audit should have a structure that includes a policy, plan, documentation of the audit activities and the reports and closure of any observations. There are critical processes and direct impact systems which should be the primary focus of our efforts. During an audit of a validation program, the focus should be placed on those critical processes or systems as they will affect our product quality in the most direct way. An audit of a validation program must also cover the validation status maintenance, specifically the change control program adequacy and documentation which will have a critical effect on our validation program compliance.
Why should you attend: The revised PV guideline is demanding that the industry focuses on the adequate design and qualification of facilities, systems, equipment and processes so an adequate validation program has to address these areas as well as the application of QbD designed processes.
Course Modules & Content Details:
Audit Requirements - Define Audit Scope and Plan, responsibilities and the audit process
Elements of a Validation Program to be audited:
Policy, Procedures and Handling of Deviations
Protocol Formats and Approval cycles
Training of Validation Personnel
Documentation of validation executions
Use and Control of external validation resources
Change Control - How it relates to the Validation Program?
Addressing Audit Observations and reports - prioritizing observations based on a risk-based analysis
Areas Covered in the Session:
Plan and organize for the audit
How to select the focus areas - primarily the critical processes and direct impact systems.
How to execute and document the audit results.
How to report the audit observations, the departmental response and the closure of the item.
Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-eight years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology.
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