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Risk Assessment and Risk Management
Risk Assessment and Risk Management
Risk Assessment and Risk Management
This seminar will cover the following topics:
  • Review QRM
  • Definition of risk
  • Regulatory expectations
  • Benefits of Risk Management and Risk Management
  • History of Risk-Management in Biopharmaceuticals
  • Overview of ICH Q9
  • Overview of ASTM E-250
  • Risk Assessment Tools
  • Risk Assessment Facilitation Process using FMEA

  • At the conclusion of this session, participants will be able to:
  • Understand regulatory expectations
  • Understand ICH Q9 and ASTM E-2500
  • Risk Assessment Facilitation Technique using FMEA
  • Risk Management
  • FMEA Processes
  • New Product Introduction Risk Assessment

  • Speaker Biographies:
    Stephen K. Yu is currently Managing Director, Bayesian-Consulting LLC, and has successfully conducted risk assessments for several BioPharm clients, and contributed significantly to project ROI. He was previously Director of Production Engineering at AstraZeneca, and responsible for the management of strategic capital projects for the U.S. manufacturing sites. He is a frequent speaker on the topics of solid dosage, biotech process design, and quality risk management at ISPE and Interphex conferences, and has published on the subject of 'Biotech Facility Construction'. He has in-depth working experience with FDA and EU regulatory compliance requirements. Yu is the leader of the ISPE OSD Baseline Guide Revision Team, a member of the ISPE C&Q Risk-Based Approach team, and a member of the ASTM E-2500 Standard Team. He holds a degree in Chemical Engineering from New York University's Associate Director, Office of Manufacturing and Product Quality, Center for Drug Evaluation and Research (CDER), Office of Compliance, FDA. In this position, he is responsible for oversight of CGMP and drug quality programs to assure scientific and risk-based decisions. This position includes review of major regulatory action recommendations regarding inspections and manufacturing site acceptability; promoting sound risk management of major defects (e.g., potential recalls); program prioritization; and analyzing emerging drug quality trends. Mr. Friedman is also the co-chair of FDA's Pharmaceutical Quality Systems Workgroup, the Standards Working Group, and the CDER/ORA Strategic Science and Compliance Committee.

    Rocco Duran has over twenty-nine years' experience as a pharmaceutical industry professional. Duran has a role of increasing responsibility in the areas of Manufacturing, Technical Services and Quality. He has worked for four major pharmaceutical companies: Warner-Lambert/Parke Davis Division, Sandoz, GSK and AstraZeneca. Duran had roles with various pharmaceutical dosage forms including aerosols, topicals, injectables, tablets and capsules. He is knowledgeable and has lead efforts to improve Supply Chain Operations, Lean/Six Sigma transformations, Quality Operations and Quality Management Principles. Most recently he has served as Senior Director Quality Assurance and Site Quality Lead for the AZ Newark Delaware Supply site and is currently a Senior Quality Assurance Executive within the Global Quality Operations, Strategy and System team responsible for driving the implementation of the AZ global Quality strategy.
    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: 120 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: .20 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 49.00 / € 40.00
    Non Member Price: $ 149.00 / € 110.00
    Item #: WEBRARMUS

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