ComplianceOnline Announces Seminar on GMP Expectations for Phase 1 and First-in-Man Clinical Trials

Top Quote ComplianceOnline, the leading GRC advisory network, and well known regulatory affairs expert Dr. Mukesh Kumar, will conduct a two day, in-person seminar on the FDA's GMP expectations for Phase 1 and first-in-man clinical trials. End Quote
  • (1888PressRelease) July 31, 2012 - Palo Alto, CA, USA - ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials. The two day long, in-person seminar, led by regulatory affairs expert Dr. Mukesh Kumar, will be held on August 23 and 24, 2012 in Philadelphia, PA.

    The seminar will explain the manufacturing requirements for an early development stage product for Phase I and first-in-man clinical trials. The course has been pre-approved by RAPS and participants will be eligible to receive up to 12 RAC credits toward their certification on completion.

    For more information or to register for the seminar, please click here.

    Seminar instructor Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs.

    During this interactive seminar, Dr. Kumar will present the current regulations, GMP guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Attendees will also learn the logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.

    This course will benefit anyone working in early stage clinical trials, especially directors, managers, and supervisors. Members of the quality assurance and quality control departments will also find the seminar useful. Other professionals who will benefit from the seminar include workers who will prepare GMP documents for early phase products as well as those who will review these documents. Regulatory affairs workers who will need to deal with submissions covering early phase products should also attend.

    Date: Thursday August 23rd & Friday August 24th 2012, 8:00 AM to 3:30 PM EDT

    Venue: Hampton Inn Philadelphia City Center, PA

    Registration Cost: $999 per registration

    Early bird discounts: For discounts on early registrations, please click here.

    Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare ( @ ) complianceonline dot com

    For more information on ComplianceOnline or to browse through our trainings, please visit our website.

    About ComplianceOnline
    ComplianceOnline is a leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 20,000 professionals from 3,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at

    For more information please contact:
    A Reuben Bernard
    Manager of Program Marketing
    2600 E Bayshore Rd
    Palo Alto CA USA 94303
    650-620-3937 phone
    650-963-2530 fax
    reuben ( @ ) complianceonline dot com

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