Regulatory Compliance Excellence



"Remediating Your Consent Decree, Warning Letter, Multi-483s and Quality System Challenges Right First Time and Fast By Spending Less"



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Chairman of Supplier Quality Management Congress: Assuring the integrity of drug and device raw materials ad supply chains, August 19-21, 2009, Arlington, VA. Seminar Speaker: How to convert supplier quality-related CAPA challenges into tangible benefits and competitive advantage.

Speaker and Conference Panel Member - Injection Molding, Medical Devices, Pharmaceuticals and FDA: Four key steps to develop a FDA compliant, competitive and profitable Quality System for your Injection Molding business, June 18, 2008, Engel Medical Days 2008, York, PA.

Seminar Speaker: Injection Molding Business ? Your roadmap to breakthrough quality, productivity and profitability in less than one year without "breaking the bank," March 19, 2008, SPE Susquehanna Chapter, Etters, PA.

Chairman of 3.5 hours Regulatory Compliance and Business Excellence Workshop: Regulatory Compliance and Business Excellence Lessons Learned (Seminar Speaker); Case Studies on How-To Troubleshoot Quickly and Correctly Your Material and/or Process Problems With Analytical Laboratory Expertise/Know-How; Data-Driven Methods for Regulatory Compliance and Business Excellence; Case Study - Improving Manufacturing Performance & Cycle Time at DuPont Pharmaceuticals, Interphex 2007 - April 26, 2007, New York, NY.

Seminar Speaker: Developed and presented 3 hour workshop with subject "Lean Six Sigma for Pharma Manufacturing: Benefits of Compliance" with only 4 hours prior notice and was congratulated by the seminar attendees and International Quality & Productivity Center (IQPC) Conference Director, July 24 - 26, 2006, Philadelphia, PA.

Conference Chairman: GMP Requirements, Outsourcing and Manufacturing of Active Pharmaceutical Ingredients. Seminar Speaker: Technology Transfer Strategies, 26-27 March 2001, New Orleans, LA.

Conference Chairman: R&D Alliances for Pharmaceutical/Biotechnology: Build Collaborations and Consortiums to Achieve Maximum Commercialization. Seminar Speaker: Valuation, Contracting and Licensing Agreements, Strategies for Newly Developed Technologies, 23-24 October 2000, Boston, MA.

Seminar Speaker: Technology Transfer Strategies, at Manufacturing Active Pharmaceutical Ingredients (APIs) conference: Effective sourcing and supply chain management of APIs. Cleaning validation for API manufacturing facilities. Critical strategies for API regulatory requirements, validation, outsourcing and technology transfer, 6-7 December 1999, Atlanta, GA.

Conference Chairman: Biotechnology and Pharmaceutical Conference: Patents, Licensing, Trademarks and Intellectual Property ·Strategies to maximize protection and financial profits. Seminar Speaker: Intellectual Property Valuation, 28-30 July 1999, San Francisco, CA.

Seminar Speaker: Business Transformation Through Re-engineering and Continuous Improvement - powerful models and practical strategies for an ever rapidly changing global business environment, 19 May 1999, Princeton, NJ.

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