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Regulatory Compliance: Standards, Practices, and Guides
Regulatory Compliance: Standards, Practices, and Guides
Regulatory Compliance: Standards, Practices, and Guides
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). At the conclusion of this session, participants will have 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)

  • Attendance Suggested for:
  • Years in industry: 0-4 to 5-14
  • Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s) and/or pursue the CPIP credential.

  • Instructor 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, 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. Mr. Howard earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional, and is a registered professional engineer in North Carolina.
    Discounted member price: 250.00
    You could save 47.9%
    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 35 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    ISPE CEUs: .05 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 250.00 / € 205.00
    Non Member Price: $ 480.00 / € 394.00