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FDAnews Announces Clinical Quality Assurance Workshop
Date:2/2/2013

is essential to assuring completion of everything that needs to be done
  • Conduct the audits — what do you do and what interviewing skills are needed
  • Compose the site visit audit report — writing it is sometimes the hardest thing to accomplish
  • Evaluate the audit findings and implement corrective actions — once the report is written the audit is not over
  • Master FDA inspections and avoid the top five GCP violations

  • Who Will Benefit

    • Clinical quality assurance managers and auditors
    • Clinical site directors
    • Clinical research associates/coordinators
    • Regulatory affairs
    • IRB administrators

    Register today

    Meet Your Instructor

    Michelle Sceppa , principal and founder of MSceppa Consulting, has more than 25 years of experience in quality assurance and regulatory compliance in the pharmaceutical and medical device industries. As a lead auditor, she has conducted and managed more than 300 internal and external audits for drug, biologics and medical device firms in the U.S. and Europe.

    Ms. Sceppa has implemented and managed preclinical, clinical and manufacturing quality assurance programs for numerous clients and has knowledge in the details of compliance with all U.S. federal regulations, including: good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP) for drugs, biologics and medical devices.

    Ms. Sceppa is also certified in the Q7A regulations for the manufacture of active pharmaceutical ingredients. Since 2002, she has been a faculty member of the Parenteral Drug Association's (PDA) Training and Research Institute (PDA-TRI) in Baltimore, MD.

    CONFERENCE DETAILS
    Clinical Quality Assurance
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    SOURCE FDAnews
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