ASTM (American Society for Testing and Materials) E2500: A New Approach to Validation
Instructor:
Peter K Watler
Product ID: 701165
- Duration: 90 Min
Industry groups have responded with approaches such as the ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment provides an industry consensus framework to modify many of the cumbersome validation practices. The new standard strives to simplify the verification process by leveraging commissioning activities, with the engineering designers of equipment playing the key role in its qualification. With qualification activities consuming as much as 25% of the facility cost, a streamlined method for validation has the potential to result in large cost and time savings.
Areas Covered in the seminar:
- This presentation will review how these ASTM and ICH approaches can simplify the qualification process.
- Documentation of design.
- Risk mitigation by design review and operational practices.
- The role of subject matter experts.
- Use of risk management techniques to drive the extent of systems verification and level of documentation detail.
- Acceptability of well-managed changes to systems.
Who will benefit:
- Biopharmaceutical and Medical Device Quality assurance professionals and mangers
- Validation professionals, practitioners and mangers
- Operations professionals and mangers
- Engineering professionals and managers
Peter K. Watler, Ph.D, is currently the Chief Technical Officer for Hyde Engineering + Consulting (Hyde) where he is responsible for the strategic direction of Hyde and its expansion into new technical markets. Dr. Watler joined Hyde in 2007 as the Vice President of West Coast Operations. Dr. Watler brings 19 years of process development and GMP manufacturing experience in the biotechnology industry. His areas of expertise include process validation, fermentation, centrifugation, filtration, chromatography, process modeling, capacity planning, economic/COGs analysis, facility validation and manufacturing operations. He has prepared 3 IND and BLA submissions and participated in four FDA inspections and numerous GMP audits.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
