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Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel

 
  September 22, 2010  
     
 


GlobalCompliancePanel, Online Training Webinar
2010-11-10


Auditing API producers and suppliers is an important part of GMP compliance programs.

Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are snapshots of what exists at the moment of the audit; however, a good audit or auditor will be able to uncover the less obvious signals and signs of concern. Learn what to include in an audit, what to examine, where to look, to whom to speak, and what areas are the best indicators of problems.

Being able to find hidden signs of weakness or deviations that are not obvious are key to a good audit. Developing that talent and utilizing it are vital to the success of an audit and the auditor.

Being able to discover "the smoking gun" is a key talent of a great auditor. It is always easy to criticize after a problem causes a serious issue . . . it is difficult to see the problem coming and alerting people to its risk and potential. We will cover some of the opportunities you can seize to make your audits more productive and valuable.

Why should you attend: Auditing is a learned and developed skill that plays an important role in determining GMP compliance. This program will provide the participant with insight into what one needs to do to perform an effective audit of API suppliers. What should be performed during the preparation and performance of such audits and what documents to utilize. Also examined are the processes used to communicate and follow-up after an audit is completed.

Areas Covered in the Session:

  • What does an audit need to accomplish?
  • Preparing for an API Audit
  • Initial survey questionnaires
  • Examine initial or past history with the firm
  • Identify signs
  • Addressing signs discovered
  • Looking at facilities
  • Looking at Staff
  • Looking at change controls and notification systems
  • What do purchasers of API need to do?

Who Will Benefit:

  • Quality Unit Supervisors/Managers/Directors
  • Support Functions to Quality or Manufacturing
  • Manufacturing Supervisors/Managers/Directors
  • Regulatory Affairs personnel responsible for GMP Compliance and filings
  • Support personnel responsible for GMP Related activities such as Calibration and Testing Functions
  • Validation personnel
  • R&D Professional, Supervision and Management
 
 
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: 2010-11-11
 
Registration:

  Live live online training only for one participant
Price: $245.00

Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)

Price: $995.00

 

E-mail: webinars@GlobalCompliancePanel.com
 
   
 
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