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Manufacturing of Potent Drugs: An Industry Perspective on Fa
Manufacturing of Potent Drugs: An Industry Perspective on Fa
Manufacturing of Potent Drugs: An Industry Perspective on Facility Design, Measurements, and Controls as Presented to the FDA
This session was presented to the FDA as a follow up to the June 2005 ISPE Conference, Edwin Melendez requested several speakers to provide information to the FDA on Manufacturing of "Potent Drugs": An Industry Perspective on Facility Design, Measurements and Controls. The content of this presentation is based on the knowledge and experiences of the speakers and is not meant to be an industry approved consensus. The following presentation is the direction the industry should be heading, it is not a representation of the current state. The main objective of this presentation is to have continuing dialogue on:
  • Controlling exposure to pharmaceutical compounds that leads to development of guidance that is based on rigorous science

  • Speaker Biographies:
    Julian Wilkins is founder and vice president of PharmaConsult US, Inc. He has over 30 years of professional experience in architecture and containment solutions for the pharmaceutical industry. He has designed and managed the manufacture and qualification of containment systems for potent and aseptic compounds. In 1991 Julian co-founded a pharmaceutical isolator company in the UK and in 1999 founded PharmaConsult US, a consulting company that is dedicated to controlling product and people exposure in the pharmaceutical and biotech industries. He understands all aspects of Risk, Hazard and Exposure of People and Patients in the Pharmaceutical Industry, with particular emphasis on Exposure Control measures. Julian has assisted many clients in assessing their risk of cross contamination and operator exposure. From these risk assessments plan of actions are developed to assure that the high-risk areas are addressed while the low-risk areas are identified. Julian is also a founding member of the UK affiliation of ISPE, founding Chair of ISPE Containment COP and a core Team Member of the ISPE ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP). He has given many papers worldwide at ISPE, PDA, Cleanrooms and Interphex.

    Stephanie Wilkins, PE, Lean Six Sigma Green Belt, has over 30 years of professional experience in project management, risk management, engineering and validation solutions for the pharmaceutical and biotech industry including research, development, and pilot plant and manufacturing facilities. She is president of PharmaConsult US, Inc, which provides cross-contamination and containment consulting to the pharmaceutical industry. Wilkins, a member of ISPE since 1993 is the co-Chair of the ISPE Risk-MaPP Baseline Guide Task Team and was a member of the ISPE International Board of Directors. Wilkins also is a reviewer for articles to be placed in the Pharmaceutical Engineering Journal as well as contributed articles, given lectures and organized courses for ISPE. Wilkins graduated from the Pennsylvania State University with a Bachelor of Architectural Engineering.

    Paul Wreglesworth has a BSc (Hons) in pharmacy and has more than 30 years' experience in the Pharmaceutical Industry with considerable experience of the development, manufacture and sourcing of pharmaceuticals gained at both local site and corporate level. He is recently retired from AstraZeneca in the UK where he was global technology director with specific responsibility for manufacturing technology strategy. Prior to taking on that role Paul was New Product Director with responsibility for the manufacturing strategy for the Company's anti-cancer products in which position he developed a particular interest in the handling of hazardous compounds. Paul has been a core member of the team that drafted the ISPE RiskMaPP guideline currently under review by FDA and has spoken extensively on the topic in Europe, North America and Asia.
    Discounted member price: 49.00
    Your price: 149.00
    You could save 67.1%
    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: 60 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: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 49.00 / € 45.00
    Non Member Price: $ 149.00 / € 136.00

    Publishing Date: 05/06

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