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Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO) - Webinar By GlobalCompliancePanel

 
  April 12, 2011  
     
 


GlobalCompliancePanel, Online Training Webinar
2011-05-18


Overview: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing.

API manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements, what are the key contractual requirements and what should be negotiated and documented within quality agreements with a CMO firm.

Why Should You Attend: Attending this webinar will help you identify what you need to know and examine during an audit of your CMO or API suppliers. The webinar leader will help you identify key regulatory and industrial 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 controlled. Such examination is not always productive if you rely simply on testing protocols. You need to learn where to look and what to focus on during any on-site audit. 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:
  • Examine key elements of an API audit
  • Audit preparation
  • The audit itself
    • Opening Session
    • Audit itself
    • What to look for?
    • Discussion of findings
    • Suggestions and experience
  • Closing Meeting
  • Who should participate in audit
  • Who should attend openning and closing sessions
  • Audit Reports
  • Follow-up Actions
  • Agreed upon Schedules
  • Follow-up Audits
Who Will Benefit:
  • Supervisors and Managers in Manufacturing
  • Supervisors and Managers in Quality
  • Engineering
  • Maintenance Supervisors and Managers
  • Warehousing and Materials Management Supervisors and Managers
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: Max S. Lazar is President, FDA Regulatory Compliance Consulting. He retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals (Solid, Liquid, and Sterile), R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard, Max is uniquely qualified to share and explain the EWG's intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself. His more than 40-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association's Bulk Pharmaceutical Committee of the Quality Control Section. This chair lasted thru the reorganization of PMA into PhRMA and until Max's retirement in 2001. He has presented at numerous meetings and training programs including SOCMA, PDA, DIA, PhRMA, Barnett, and IIR both domestically and overseas.
 
Deadline for Abstracts: 2011-05-18
 
Registration: Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
E-mail: webinars@GlobalCompliancePanel.com
 
   
 
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