Member Services
Online Course
Standards, Practices, and Guides 
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Duration: 35 Minutes |
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Purchase from ISPE's Online Store
CPIP™ Knowledge Elements
- Regulatory Compliance
Presenter
- Tim Howard, PE, CPIP, Commissioning Agents, Inc.
Explore the role industry-generated guidance plays in relation to international harmonization (i.e., ICH guidance documents, ISPE Baseline® Guides, GAMP® and ISPE Good Practice Guides; and the PDA technical reports), and the function of common environment, health, safety, and consensus standards (ISO, ANSI, ASTM).
Learning Objectives
Knowledge of:
- Industry-generated guidance relating to international harmonization (ICH guidance documents; ISPE Baseline Guides, GAMP, and Good Practice Guides; and the PDA technical reports)
- Common environment, health and safety standards
- Consensus standards (ISO, ANSI, ASTM)
Presenter Biography
Timothy Howard, PE, CPIP, has over 13 years of experience in pharmaceutical and biotechnology plant commissioning, qualification, and validation. He is currently the C&Q Business Area Lead for Commissioning Agents, Inc. Previously he was with Eli Lilly at a green field site, responsible for leading the C&Q effort and later the maintenance and facility engineering departments. He has been active with ISPE since 1996, is a current board member of the Carolina-South Atlantic Chapter, served on the North American Education Committee since 2002, and is the current co-chair of the NAEC. He is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Howard earned a B.S. degree in mechanical engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional™ (CPIP™), and is a registered professional engineer in North Carolina.
Related Communities of Practice (COPs)
API, Biotech, C&Q, Containment, Disposables, ESB, GAMP, GCLP, HVAC, IP, OSD, Operations Management, Packaging, PAT, PPD, PM, and SPP
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.
What are CPIP™ Online Courses?
CPIP™ Online Courses were developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional™ (CPIP™) examination.
The Certified Pharmaceutical Industry Professional™ (CPIP™) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these courses does not guarantee successful completion of the CPIP certification exam, and these courses do not include every subject to the depth of what will be covered on the CPIP exam.
Online courses can be viewed at your convenience. For courses purchased online: an order confirmation containing a link to the course will be sent automatically, immediately after purchase. After receiving the link to the course, you have 5 days to view it. For courses 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 course. After receiving the link to the course, you have 5 days to view it.
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