Surviving an FDA Sponsors Inspection - Training for success

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Surviving an FDA Sponsors Inspection - Training
for success
www.onlinecompliancepanel.com 510-857-5896
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Instructor Profile

• Stephen Schwartz CIC founder of
  Commonwealth Clinical Research Services (later as
  Solaris Research Corporation), a full service CRO
  from 1989 to 2009. He has a degree in
  microbiology/infectious disease. Steve worked in
  clinical project development for Pharma for 16
  years and for 20 years as a CRO with experience
  in devices, biological, diagnostics, and
  therapeutics in most of the areas of clinical
  research for all study phases, as well as
  pre-clinical activities.Steve has extensive
  field experience as a CRA and as a CQA auditor,
  He has expertise in Clinical Operations,
  including the functions of clinical monitoring,
  program management, product development, CQA, and
  inspectional operations. He has recently retired
  from Pharma where he was Sr Manager, Global
  Clinical Operations. His current activities as a
  consultant include CQA inspections and training,
  Gap Analysis Audits, and Clinical Project
  Oversight.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Description
• FDA investigators (auditors and
  inspectors) are thoroughly trained in interview
  methods that will yield clues to GCP
  non-compliance, the sources of the
  non-compliance, the documentation of the
  non-compliance, and the sponsors intent
  (presence of misconduct or fraud) in the conduct
  of the non-compliance.
• Why Should you Attend This webinar will teach
  you how to identify the non-compliance
  liabilities within your program and how to
  anticipate and respond to direct interview
  questions specific to those non-compliance
  issues.
• Who can Benefit
• Pharma staff at the Director, Manager and
  Operational Levels for Research and Clinical
  Development
• Pharmacovigilance
• Medical Affairs
• Pharmacy Research
• Regulatory Affairs
• Data Management.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Live Session - How it works
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• Get certification of attendance.

• Recorded Session - How it works
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be
  mailed to you
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com