What: Global Pharma Manufacturing Summit
When: September 8-9
Where: Marriotts Evergreen Conference Resort, Atlanta, Ga.
Description: The pharmaceutical manufacturing industry is an industry under pressure. Pressure to innovate and streamline manufacturing operations, reduce cost and time to market whilst meeting compliance and regulatory standards. The world's top pharmaceutical manufacturing professionals will meet at the Global Pharma Manufacturing Summit to discuss the issues that they are focusing on today, including lean-manufacturing, MES, outsourcing manufacturing and implementing successful technology transfers.
- A Multi-Scale Perspective on PAT -- Charles Cooney, Co-Director, Sloan Pharmaceutical Program, MIT
- Approaches to the Acquisition &Amp; Management of Regulatory Information Under FDAs 21st Century Quality Initiatives -- Dhiren Shah, Director CMC US Regulatory Affairs, Aventis
- The Quest For Excellence In Pharmaceutical Manufacturing, Industry Perspectives on Quality 21st Century Initiatives -- Eilleen Morrissey, VP Global Operational Excellence, Merck
- Protecting the Ever-Complex Supply Chain, A Global Regulatory Perspective -- Eshetu Wondemagegnehu, Technical Officer and Focal Person, for Counterfeit Drugs, World Health Organization
- "Anti-Counterfeit Solution -- Use of EPC Global Standards" -- John Roberts, Director, Healthcare, Uniform Code Council
- Future Implications of PAT -- Dr. Melvin Koch, Director, Center for Process Analytical Chemistry, University of Washington
- Science-Based Project Management & PAT -- Dr. Stephen Byrn, Head, Department of Industrial & Physical Pharmacy, Purdue
Contact: Stewart Press, Executive Vice President
World Trade Group (North America) Inc.
20 Toronto Street, Suite 900
Toronto, ON M5C 2B8
T: 1 416 214 3400
F: 1 416 214 3403
What: Formulating for Nutritional Supplements course
When: September 8-9
Where: Los Angeles area (call for details)
Description: "Formulating for Nutritional Supplements" is a new two-day introductory course on formulating nutritional supplement tablets and capsules. This course is engineered from the bottom up for new formulators, nutritionists now formulating products and new or small business owners looking for formulating information in a basic, fast course. The graduate will both pass an open-book written examination and successfully construct a nutritional supplement formula before being certified.
Contact: Solid Dosage Training Inc.
497 Phoenix Circle
Vallejo, Calif. 94589
What: Conformia's Scale-Up Optimization Quarterly Breakfast Seminar
When: September 9
Where: Hyatt Regency, Princeton, N.J.
Description: This seminar is focused on exploring current events and issues facing Pharmaceutical Process Development arena.
Our inaugural event will be chaired by Ken Morris along with Ajaz Hussain from the FDA's Office of Pharmaceutical Sciences. The program topic "Optimizing Pharmaceutical Development: Implementing ICH Q8 Guidelines for Better Process Understanding" will allow development chemists and engineers the opportunity to learn how they can incorporate the principles and objectives outlined in ICH Q8 to improve their development operations. Specifically, this interactive session will allow attendees the opportunity to discuss what organizations should consider when designing chemical and/or bio routes as well as the supporting scale-up business and information processes needed to ensure alignment with the ICH guidelines. Issues of risk-management, specifications, operating parameters, and design requirements for scale-up as a product evolves across the development lifecycle will be explored and discussed.
The talks will be followed with a real-life case study detailing how a Top 10 Pharmaceutical Company was able to build and define its design space by getting control of its information management capabilities. The presentation will detail how the company was able to leverage information into a framework of effective knowledge management one that served as a catalyst for achieving the benefits of implementing an optimal design space. The case will be particularly useful for those executives whose organization's Process Understanding initiatives are hampered by lack of adequate business processes and/or supporting information management capabilities.
The seminar will close with a panel discussion entitled "From Concept to Practice: Prescription for Implementing ICH Q8 and Process Understanding Concepts in Industry."
Space is limited so register early! If you are interested in participating in this event, please RSVP by August 25, 2005.
Contact: Phone: 781-593-7244. E-mail: email@example.com; website: www.conformia.com/news/events/rsvp09082005.html
What: SAP's RFID & Manufacturing Compliance Summit
When: September 12
Where: Millenium Broadway Hotel, New York City.
Description: Learn how life sciences companies are achieving RFID and manufacturing compliance. Co-sponsored by SAP, HP, Zebra and Nokia, the summit examines solutions to help life sciences firms:
- Manufacture products that meet quality, safety and compliance requirements, and document all process changes;
- Compress clinical supply chain cycles and improve the scale-up process from clinical to commercial manufacturing;