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FDAnews Announces Leading the Climb: Seven Essentials of GMP Workshop
Date:7/19/2013

why, how and what you are doing before you do it
  • Document all activities
  • Strive for consistency and control – qualification, validation and change management
  • Have management that supports an independent group that makes final decisions on documents, product release and quality
  • Learn from mistakes and solve problems while continuing to monitor and improve
  • As the regulatory environment changes and manufacturing best practices evolve, so does GMP. Stay current by attending this two-day workshop (Aug. 19 and 20) in Philadelphia, Leading the Climb: Seven Essentials of GMP. Register now to learn:

    • The personal, regulatory and business consequences of failing to meet GMP expectations in pharma and biopharma manufacturing
    • Technical and leadership skills
    • Key words and concepts related to good manufacturing practice
    • How regulations, guidelines and best practices contribute to current GMP expectations
    • The many ways quality system elements affect your role
    • How auditors and regulatory inspectors will evaluate you
    • Ways to satisfy the seven GMP essentials during emergencies
    • What's expected of personnel at all levels on the pharma and biopharma manufacturing chain

    Information You Need from an Authority in the Field

    Presenter James Vesper designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. He is founder and president of LearningPlus, Inc., and has more than 30 years' experience in the pharmaceutical industry, including 11 years at Eli Lilly. His work there included serving as project leader of GMP education and instruction. He also presents papers and workshops at various international technical and professio
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