Share: Facebook Twitter GooglePLus LinkedIn
Activity Provided By:



Access Activity

Overview / Abstract:

The installation/operational/performance qualification/ verification of equipment, systems, facilities and processes for pharmaceutical sterile, oral solid dosage biologics, finished and bulk manufacturing operations are an essential part of the validation process. Equipment must be installed, operated and maintained within design specifications and facilities must be accepted as fit for use, while processes must be shown to be reliable, all of which to assure the consistent quality and integrity of the product. This course provides a basic and thorough understanding to preparing, executing, reviewing and approving protocols. A Risk Based approach to impact critically assessment is also provided along with an overview of ICH Q9 Quality Risk Management and ASTME 2500 International Consensus Standard approaches now being applied by the Industry and Regulatory authorities to define Qualification (Verification) requirements.

Protocol examples/workshops will be utilized to enhance the learning, however this course will not provide a library of completed protocols.


May 02, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.2 CEUs



Presenters / Authors / Faculty

Steven J. Wisniewski; Principal Compliance Consultant, Commissioning Agents, Inc. (CAI)

Keywords / Search Terms

CfPA IQ/OQ/PQ, Preparing and Conducting Installation, Operational and Performance Qualifications, ICH Q9/ASTM, PQ/OQ Structure, PQ/OQ Acceptance Criteria Seminar CE CME

LIVE Activity Location Details

04-30-2018 - 05-01-2018

Amsterdam, The Netherlands

Access Activity

RXinsider,, and our advertising partners do not endorse and do not verify the accuracy of the content in the activities presented on the website or within our mobile apps. RXinsider,, and our advertising partners are not responsible for errors, omissions, or misrepresentations contained within activities presented on the CESearchEngine website or or within our mobile apps. For complete details, please read the Terms of Service. Site Map.