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..

Timothy P. Howard, CPIP, PE is a Vice President of Strategic Development for CAI and serves as Vice President for CAI-Asia Operations. Mr. Howard consults globally on a range of topics for the biopharma industry including quality risk management, Project Management, C&Q program implementation, and risk-based validation programs. Mr. Howard has been on the International Board of Directors at ISPE since 2011. An ISPE Member since 1994, his service to ISPE includes Past Chair of the ISPE University Committee, Co-Chair of the C&Q CoP, and CaSA Chapter Board member. He was a long-time member of ISPE’s Continuing Education Committee, having served as Chair and Co-Chair for three years. Mr. Howard was a member of the ISPE Task Team that developed the ASTM standard E2500 and a contributing author to ISPE Guidance Documents on ASTM E2500 Implementation. He is a qualified trainer for the ISPE training course on C&Q applications, regularly speaks at conference seminars worldwide, and is published in Pharmaceutical Engineering. Tim previously worked with Eli Lilly, 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 a licensed Professional Engineer in North Carolina.

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