Standards, Practices, and Guides

Session Type: Recorded Webinar
Knowledge Element: Regulatory Compliance (Includes drugs, environmental, health, and safety)
Speaker: Tim Howard
Duration: 30 minutes

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This course provides an overview of the multitude of Standards, Guidelines, and Best Practices documents that are available to pharmaceutical and biotechnology professionals. This course specifically excludes discussion on GMP’s, regulatory bodies that enforce the GMP’s and global compendial documents. The course reviews consensus based organizations that publish standards, society based organizations the publish best practice and baseline guides, and regulatory documents (excluding GMPs).

Learning Objectives:

• Discuss consensus based organizations, the standards available from these organizations, and how to view or obtain the materials 
• Discuss society based organizations and the reference material they author 
• List some of the societies that publish materials relevant to the biotech/pharma industry (not just societies dedicated to this industry) 
• Find applicable resources on the individual organizational Web sites 
• Understand how to find guidance and standards for health, safety, and environmental topics

Who Should Attend:

• All pharmaceutical and biotech professional that are unfamiliar with ISO, ICH, ASME, ANSI, ISPE, PDA, OSHA, EPA, ASTM, ISA, and the materials these organizations author that apply to industry professionals daily job function

Speaker Biography

Timothy Howard, PE,has more than 12 years of experience in pharmaceutical and biotechnology plant commissioning, qualification, and validation. He spent 3½ years with Eli Lilly at a green field site, responsible for leading the C&Q effort and later the maintenance and facility. He has been active with ISPE since 1996, is a former board member of the Carolina-South Atlantic Chapter, has 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 and is a registered professional engineer in North Carolina.

What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration 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.

What are CPIP^SM Recorded Webinars?

CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination.

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) 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 seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.

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