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Implementing the ASTM Standard for Verification (C&Q) |
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| 80 Minutes | Members: $49 Nonmembers: $149 |
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Presenter
- Steven J. Wisniewski, Senior Associate and Director of Compliance, IPS
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Relate the ASTM Standard to GMP regulations and guidance documents
- Explain the regulatory foundation for the risk-based approach
- Understand the 2001 ISPE Baseline® Guide: Commissioning and Qualification Volume 5 and how it links to new concepts in the upcoming Baseline Guide: Science and Risk-Based approach for the Delivery of Facilities, Systems, and Equipment
- Differentiate qualification versus verification
- Differentiate between the new risk assessment approach versus the old one
- Understand how the new draft USFDA Process Validation Draft links to ASTM E 2500
- Understand the details on verification process flow
- Implement verification through the C&Q process (FAT, SAT, IV, FV, PT)
- Understand ways GEP can be used as a foundation for verification
Description
Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: “fit for use,” perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle
Who Should Participate
Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.
Presenter Biography
Steven J. Wisniewski is Senior Associate and Director of Compliance for Integrated Project Services (IPS), a full-service engineering firm specializing in the delivery of technical complex projects, and that offers complete design/build, commissioning, validation and FDA compliance services for the pharmaceutical, biotech, health care, and specialty manufacturing industries. Wisniewski has more then 30 years experience in the pharmaceutical, biotech, and device industries. Currently, Wisniewski is chairman of the ISPE Community of Practice for Commissioning and Qualification, and is on the ISPE task team developing the revised ASTM Verification Standard and the new C&Q Baseline® Guide: Science and Risk-Based approach for the Delivery of Facilities, Systems, and Equipment, Volume 12 to support implementation of ASTM E 2500.
Related Communities of Practice (COPs)
C&Q, API, CU, GAMP, HVAC, OSD, PM, and SPP
More information on Communities of Practice (COPs)
CPIP™ Knowledge Elements
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This Webinar relates to the following CPIP™ Knowledge Elements: |
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General Information
ISPE CEUs: .15
Continuing Education Units
ISPE will provide continuing education units (ISPE CEUs) for webinars and online courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance and completion of the evaluation. Statements of credit will be sent via email upon request within four weeks of evaluation materials; one CEU per paid attendee. One hour of education programming equals 0.1 ISPE CEU credits. Email cgarcia@ispe.org and provide your name, the webinar name, the date you attended, and the registered participant email address.
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Recorded webinars can be viewed at your convenience. For Recorded Webinars purchased online: an order confirmation containing a link to the Recorded Webinar will be sent automatically, immediately after purchase. After receiving the link to the Recorded Webinar, you have 15 days to view it. For Recorded Webinars purchased via mail, fax, and telephone: orders are processed within two business days, after which participants will receive an email confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.
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