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MISSION STATEMENT Providing scientific and regulatory consultant services to the global pharmaceutical, dietary supplements and medical devices and diagnostic products industries
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IRA R. BERRY 90 Wild Dunes Way Jackson, New Jersey 08527 (732) 833-1666 (Office)
EXPERIENCE Recognized health care manufacturing industry expert, with a blend of technical and business education and expertise in global manufacturing, quality assurance, regulatory affairs, marketing and new business development, project management. Technical expertise in pharmaceuticals, nutritional supplements, dosage forms and APIs, medical devices and diagnostic products and cosmetics, complemented with strong written and verbal communication skills. Commitment to industry demonstrated through organizational contributions as well as numerous presentations, publications and patents.
1/2002 – present INTERNATIONAL REGULATORY BUSINESS CONSULTANTS, L.L.C. President and founder
§ Personnel training for domestic and foreign plant audits for CGMP § API and dosage form activities § Preparing and filing DMFs and ANDAs for efficient product approvals § Facility and documentation CGMP upgrade programs, eg, SOPs and Quality Manuals § Create and lead teams for regulatory compliance and expedited product approvals § Facilitate global regulatory relationships o In 2004 and 2009 invited by Chinese sFDA to present two-two CGMP day workshops o Worked with a Chinese manufacturer to resolve four FDA Warning Letters § Establish joint ventures with marketing partners § Manage projects for new product development
6/2001-12/2001 DURAMED PHARMACEUTICALS, INC., Somerset, NJ (merged with Barr) Senior Vice President, Quality
§ Corporate responsibility for Quality Assurance and Quality Control
1996-5/2001 WOCKHARDT AMERICAS INC., East Hanover, NJ Executive Vice President
· Responsible to coordinate global regulatory affairs, compliance and quality assurance operations for manufacturing operations and product registrations · U.S. manufacturing and technical operations · Establishing new manufacturing operations worldwide · Company liaison with worldwide regulatory agencies · Oversee the R&D operation to develop a new line of pharmaceutical products for global product registrations
1980-1996 BANNER PHARMACAPS INC., Union, NJ Corporate Vice President - Technical Affairs 1992-1996
· Responsible to coordinate and establish a Corporate Total Quality Management program throughout the Company's 6 plants worldwide · Coordinate and develop standard validation programs for all plants · Provide technical and regulatory assistance to implement the operation of new manufacturing facilities · Oversee the development of generic drugs to market · Coordinate a technology transfer program · Obtained FDA approval for 2 generic drugs in the U.S., one of those being the first generic on the market and increasing Company profits by 100% · Coordinate regulatory activities throughout the Company · Create a cohesive management team · Provide technical assistance to Sales and Marketing
Corporate Vice President - General Manager & Technical Affairs 1990-1992
· Responsible to manage a manufacturing plant as a cost center and also to coordinate and establish a Corporate Quality Standards program throughout the Company · Reduced the labor headcount by 10% through capital expenditures for upgraded equipment · Initiated a plan to establish uniform corporate quality standards through all plants
Pharmacaps, Inc., Elizabeth, NJ 1988-1990 Executive Vice President
· Responsible to manage the plant as a cost center, to manufacture pharmaceuticals, nutritional supplements and cosmetics · Reporting to me were Production/Operations, Engineering, Quality Control, Quality Assurance, Regulatory Affairs, Product Development and Technical Customer Service · Improved service and delivery to customers while establishing systems to control inventory and improve production efficiency · Increased units produced and shipped by 50% · Improved the Quality Control Laboratory function
Senior Vice President - Technical Affairs 1987-1988 Vice President - Technical Affairs 1982-1987 Director - Technical Services 1980-1982
· Responsible for QC, QA, Regulatory Affairs and Product Development · Established a state-of-the-art QC Laboratory · Established a Regulatory Affairs compliance program · Coordinated and implemented a GMP compliance program · Established a GMP documentation program · Developed new customers and new products - OTC, Rx, nutritional supplements - domestic and international
CARTER - WALLACE, INC., Cranbury, NJ Plant Manager/Director of Manufacturing Director of Regulatory Affairs
DENVER CHEMICAL MANUFACTURING CO., Stamford, CT (acquired by Carter - Wallace) QA Administrator/Regulatory Affairs Associate Manager, Chemical Diagnostics Production
PFIZER, INC., New York, NY Manager, Serum Production Manager, Product and Process Development Supervisory Laboratory Technician
EDUCATION M.B.A. Management - Adelphi University, Garden City, NY M.A. Biology - Hofstra University, Hempstead, NY B.S. Biology/Chemistry - Queens College of CUNY, Flushing, NY
PROFESSIONAL AFFILIATION HIGHLIGHTS National Association of Pharmaceutical Manufacturers (now GPhA) (Executive Committee) (Board of Directors) (Chairman Technical and Bulk Committees) Science Committee
International Generic Pharmaceutical Association Science Committee Intellectual Property Committee
Generic Industry Trade Association Representative to FDA Product Quality Research Institute (PQRI), Drug Substance Technical Committee
SUPAC-IR Guidance Development Committee (with FDA)
BACPAC Guidance Development Committee (with FDA)
Gelatin Capsule Working Group Member with (FDA) CMC Coordinating Committee
(Gelatin) BSE Task Force with FDA
PUBLICATIONS, PATENTS AND PRESENTATIONS More than 25 published papers on GMP, validation, softgels and nutritional supplements
Co-editor of Pharmaceutical Process Validation text (1993) and Validation of Active Pharmaceutical Ingredients text (2001)
Editor of The Pharmaceutical Regulatory Process text (2004, 2008)
Chapters in
the Encyclopedia of Pharmaceutical Technology – GMP
and
Numerous talks at seminars and radio shows Patents on antacids, controlled release, chewable gelatin shell and foaming bath oils Past faculty member, Fairleigh Dickinson University MBA in Pharmaceutical Marketing program
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2275 West County Line Road,
Suite 6 #324,
Jackson, New Jersey 08527 |
| www.irb-c.com |
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