David E. Auslander, Ph.D.
Dr. David Auslander has a PhD (pharmaceutical sciences) from Rutgers University, a MS degree in pharmaceutics from Columbia University and a BS in pharmacy from Long Island University, College of Pharmacy. He has over 25 years diverse experience in the pharmaceutical industry with Bristol-Myers Squibb( research scientist), Purdue Fredrick Research Center ( group leader and director), Rorer (Department Director) and Wallace Laboratories, div. Carter Wallace ( Director, Pharmaceutical Development). Since 1995, Dr. Auslander has developed a consulting practice.
He has had direct "front-line" experience with FDA for validation, preapproval and commercial launch issues He has audited facilities, worldwide for FDA-preapproval and cGMP compliance and has set up successful PAI and validation programs for drug substances (APIs ) and drug products. In addition, Dr. Auslander has worked with extensively with all conventional dosage forms, i.e., solid dosage systems, semi-solids, parenterals and specialized delivery systems.
Jerry Dalfors has had extensive (29 years) consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. Prior to his current position as Principal, JD Technologies, he held management positions with major pharmaceutical and biotechnology companies as Div. Dir., Pharmaceutical Operations; Dir. Technical Services; Validation Manager; Marketing Manager; Project and Process Engineer, and as the Quality Assurance Testing Manager. Since then he has assisted more than a dozen clients with their documentation systems, FDA briefing documents, validation efforts, facility and product design / review for regulatory compliance issues, and has written the submission documents for product and facility approval/licensing.
JD Technologies: http://www.jdalfors.com
Robert Kieffer, Ph.D
Dr. Kieffer is a recognized authority on the design and implementation of quality systems with 30 years experience in the pharmaceutical industry. He combines broad-based business, scientific and technical knowledge with skill as a teacher, facilitator and problem solver to achieve lasting results and enhanced organizational capabilities. He specializes in the following areas:
Development of Quality Systems and their management
Development of business and quality plans
Quality Organization: design and management training
Audits, training, improvement plans for FDA GMP, ISO 9000 and Malcolm Baldrige
Training: validation quality tools, process reengineering, risk analysis, root-cause analysis
Certified Six-Sigma Black Belt professional with over 25 years experience working and consulting with major corporations. A Certified Quality Engineer and Lead Quality Systems Auditor with B.S. and M.S. in Chemical Engineering. Results-oriented problem solver accustomed to pursuing system improvements and reducing waste while maintaining customer focus. Providing consulting and auditing services in Performance Excellence, Six Sigma Improvement Methodology, Supply Chain Management, and Quality/Environmental Systems Compliance to the process and service industries. Major accomplishments in the last 8 years include application of six sigma methodology to improve processes; achievement of International ISO-9000 quality systems certification at six US facilities; QS-9000 automotive quality systems certification at three US facilities and ISO 14000 certification at one US facility. Extensive experience in third-party assessment of US manufacturing and service companies to the ISO 9000:1994 and ISO 9000:2000 Standards.
FY Consulting: http://www.fyconsulting.comdownload resume