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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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September 11, 2011 |
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global compliance panel, Online Training Webinars
2011-09-20
Why you should attend: When one considers outsourcing an internally produced material or purchasing from external suppliers, where should you focus your efforts? What is important to your business success from a business, quality and safety perspective? Purchasing materials can be a mine field of risks which need careful consideration to protect you from quality and safety pitfalls. Purchasing materials or services from a local supplier can be a totally different experience from sourcing your API, excipients or materials from foreign locations. Even the FDA is becoming frustrated with problems that are being encountered by the growing international economy. If you are a member of the pharmaceutical industry that is caught in the middle of this challenge, you may benefit from this webinar as the presenter discusses steps to take to reduce your risks and exposure to this growing "combat zone".
Areas Covered in the Session:- FDA Current position
- What to look for when selecting a supplier
- What risks are possible
- What risks are not reasonable?
- What do you need to do to establish a sound supplier relationship?
- Verify your systems and their supplier systems
- Measure the suppliers reliability and sources
- Establish an historical review.
- Do you know enough about the supplier to truly evaluate your risks?
Who Will Benefit:- Manufacturing managers and supervisors
- Quality Control and Quality Assurance Managers and Supervisors
- Chemical Engineers responsible for manufacturing of API / Excipients
- Materials Managements personnel such as purchasing agents and management
- R&D Management for product sourcing
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Organized by:
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global compliance panel |
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Invited Speakers:
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Max Lazar 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.
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Deadline for Abstracts:
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2011-09-20
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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webinars@globalcompliancepanel.com
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