Surviving an FDA Sponsors Inspection Training for success
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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@onlinecompliancepanel.com
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 sponsor’s 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit: •
Pharma staff at the Director, Manager and Operational Levels for Research and Clinical Development
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Pharmacovigilance
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Medical Affairs
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Pharmacy Research
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Regulatory Affairs
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Data Management.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works •
Username and Password will be sent to you 24 hours prior to the webinar
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Presentation handouts in pdf formate will be mailed to you
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Login to the session using the username and password provided to you
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Get answer to your queries through interactive Q&A sessions via chat
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Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
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Get certification of attendance.
Recorded Session - How it works •
A link will be provided to you upon purchase of the recorded session
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Please click on the link to access the session
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Presentation handouts in pdf formate will be mailed to you
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Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Reach us on : www.onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com