ASTM (American Society for Testing and Materials) E2500: A New Approach to Validation

Instructor: Peter K Watler
Product ID: 701165
  • Duration: 90 Min
This ASTM E2500 training will review how these ASTM (American Society for Testing and Materials) and ICH (International Conference on Harmonization) approaches can simplify the qualification process.


Regulatory groups have responded by providing guidance documents such as ICH Q9: “Quality Risk Management” which encourages a level of risk appropriate to safety and efficacy and provides a toolbox of risk management methods. ICH Q8: “Pharmaceutical Development” encourages the use of scientific methods to mitigate risk through concepts such as Design Space, Quality by Design (QbD), Process Analytical Technology (PAT) and Continuous Verification.

recorded version

$299.00 (91%)
Save $274.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jan-2009

Training CD / USB Drive

$500.00 (70%)
Save $351.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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

Instructor Profile:

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.

Follow us :
Medical Device Summit 2020
The Veterinary Drug Approval Process and FDA Regulatory Oversight

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed