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Regulatory Compliance: Government Regulations
Regulatory Compliance: Government Regulations
Regulatory Compliance: Government Regulations
Learn more about worldwide regulatory bodies, including their structure and operations, legislation, regulations, guidance, and MRA's (i.e., types of regulatory filings, GMP's). Use global compendia and know the requirements of regulating bodies around the world and awareness that differences exist. At the conclusion of this session, participants will have knowledge of:
  • The role of regulatory bodies worldwide and their structure and operations
  • The role of legislation, regulations, guidance, and MRAs worldwide (for example, types of regulatory filings, GMPs)
  • The use of global compendia
  • The common base in requirements of regulating bodies around the world and awareness that differences exist

  • 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).

  • Instructor Biography
    Kate McCormick of Heathside Information Services Ltd, UK, is a manufacturing consultant with extensive strategic and operational management experience in the pharmaceutical industry, both in the U.K. and internationally. Kate has 10 years of line management and 20 years of internal and external consulting experience. She has worked with multinationals, SMEs, non-governmental organizations and national regulatory authorities in more than 50 countries. She is the author of Quality (a textbook within the Butterworth Heinneman pharmaceutical engineering series) and Manufacturing in the Global Pharmaceuticals Industry, the editor of gmp Review and a regular speaker at international conferences.
    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: 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: $ 250.00 / € 205.00
    Non Member Price: $ 480.00 / € 394.00