This Validation training will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation.
It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation. Domestic and international regulations contain the requirements to verify that the process yields output that is both safe and effective, and meets all requirements. These requirements are also applicable to manual, "un-automated" processes. This webinar will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation. These recommendations will address the challenges most commonly experienced during validation. Also covered will be the validation technique used for processes that are already in place.
Areas Covered in the seminar:
- What is Validation?
- When should it be used?
- Validation vs. Verification: Which One?
- Different types of validation: Advance, retrospective, and concurrent
- Protocol preparation.
- Different types of validation.
- IQ, OQ, and PQ.
- Case studies and examples.
Who will benefit:
This webinar will provide valuable assistance to all companies that incorporate processes into their manufacturing, testing, or inspection processes. The employees who will benefit include:
- R&D personnel and management
- Process and Quality Engineers
- QA management
- Regulatory management
- Consultants
- Quality system auditors
Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
