Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)

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Auditing an Active Pharmaceutical Ingredient (API) Contract
Manufacturing Organization (CMO)


Course "Auditing an Active Pharmaceutical Ingredient (API)
Contract Manufacturing Organization (CMO)" has been pre-

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approved by RAPS as eligible for up to 1.00 credits towards a
participant's RAC recertification upon full completion.
Date & Time:
Instructor Profile:
Tuesday, July 24, 2012
10:00 AM PDT | 01:00 PM EDT
Max Lazar
Duration: 60 Minutes
Instructor: Max Lazar
President, FDA Regulatory
Compliance Consulting
Location: Online
Price : $245.00 (for one participant)
Max Lazar retired from Hoffmann-
La Roche Inc. in 2001 after 35 years,
Overview:
where he was Vice President, FDA &
Auditing an API CMO or any API supplier is a specialty that requires
DEA Compliance. In that position he
knowledge and experience that is gained through exposure to the
was responsible for compliance
unique attributes associated with API manufacturing.
oversight of all of the Roche USA
businesses including Active
Pharmaceutical Ingredients,
API manufacturing has similar regulatory GMP expectations as drug
Pharmaceuticals (Solid, Liquid, and
products, but not identical in is specific requirements and
Sterile), R&D, Diagnostics, Fine
application.ThenatureofAPI manufacturing and its usual purification
Chemicals and Vitamins. Following
processes all influence how an API process should operate. Knowing
his retirement, he established a
what the FDA expects and how these regulators apply API GMP is
consulting business specializing in
important to API purchasers and drug product firms. Reducing risk
API GMP issues and the training of
and protecting the quality of a Drug Product (DP) is critical to the DP
personnel covering the ICH Q7A
Guidance as well as the Excipient
firm's success. The webinar will focus on the Q7 and FDA GMP
GMP (IPEC) Guidance. As a voting
requirements, what are the key contractual requirements and what
member of the ICH Expert Work
should be negotiated and documented within quality agreements
Group (EWG) that developed and
with a CMO firm.
negotiated this new international
standard, Max is uniquely qualified to
share and explain the EWG's intent
Why Should You Attend:
of this new guidance. His
Attending this webinar will help you identify what you need to know
involvement in this new API GMP
and examine during an audit of your CMO or API suppliers. The
pre-dates the ICH activity itself.
webinar leader will help you identify key regulatory and industrial
...more
issues associated with API manufacturing. You are purchasing more
than a chemical or biological material. You are purchasing a material

that can carry with it hidden risks if not properly examined and
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controlled. Such examination is not always productive if you rely
simplyontestingprotocols.Youneedtolearn where to look and
Your Necessity is our Priority
what to focus on during any on-siteaudit.While understanding the
applicable GMP is important, how to apply the GMP and what to
establish with a CMO is critical to your supply chain.
Areas Covered in the Session:

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Examine key elements of an API audit
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Audit preparation
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The audit itself
Opening Session
Audit itself
What to look for?
Discussion of findings
Suggestions and experience
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Closing Meeting
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Who should participate in audit
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Who should attend openning and closing sessions
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Audit Reports
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Follow-up Actions
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Agreed upon Schedules
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Follow-up Audits
Click here to register for this webinar
Who Will Benefit:

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Supervisors and Managers in Manufacturing
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Supervisors and Managers in Quality
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Engineering
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Maintenance Supervisors and Managers
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Warehousing and Materials Management Supervisors and
Managers
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
About GlobalCompliancePanel
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www.globalcompliancepanel.com
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