ASQ NE Pharmaceutical GMP/Quality Conference

The ASQ FD&C Divison and the ASQ Princeton Section Thank You!

We want to thank all of you that attended for making this years conference a huge success. The conference would not be a sucess without each and every one of you, so we thank you all for attending.

As we mentioned at the conference, all presentations and handouts will be available for the general public right here.  Please click on the link to download the material.

Nate Manco is Director, US Manufacturing Affairs for ECO Animal Health, a veterinary drug development company, and has previously held plant, R&D and corporate quality management positions at CooperBiomedical, Sterling Drug, Fort Dodge (division of Wyeth), and Sandoz.  Nate has been teaching CQA, CQE and most recently CPGP refresher courses for ASQ Princeton Section, collectively, for over 20 years, and also taught Quality Concepts and SQC courses at Middlesex County College.  Nate holds a MS in Chemistry from Seton Hall University, a BS in Biochemistry from the University of Maine, and is certified by ASQ as a CQA, CQE, CMQ/OE, and CPGP.  He is a Senior Member of ASQ, member of the ASQ Princeton Section Education Committee, past president of the Parenteral Drug Association Metro Chapter, and a member of MARSQA and AOAC.

Debra L. Pagano, MT (ASCP) is an independent consultant who operates her own company under an LLC in Pennsylvania. She has been a consultant to FDA regulated industry since 2002. In this capacity, she is a compliance consultant to the Pharmaceutical, Biologics and Medical Device Industries conducting mock pre-Approval and CGMP inspections of international and domestic firms. Her coverage for CGMP inspections has included a systematic approach with a strong focus in the microbiological laboratory, including the review of environmental monitoring programs for aseptic manufacturing as well as non-sterile manufacturing facilities. Projects have included GAP assessments for critical compliance issues and functions within the FDA regulated industry. She provides CGMP training and presentations on various FDA related topics domestically and internationally.

Debra had worked for the Food and Drug Administration for 17 years. She was the Pre-Approval Program Manager from October 1994 to October 2002 and previously held positions as drug specialist and investigator. She was a course advisory member and teacher for FDA’s Pre-Approval Inspection Training Course for Investigators and Chemists; FDA’s Pre-Approval Manager Update session; and FDA’s Basic Drug School.

She is an adjunct professor for Temple University’s Quality Assurance/Regulatory Affairs Masters Program. She has conducted numerous inspections in the pre-approval program and pharmaceutical areas and was on FDA’s Foreign International cadre. Debra holds a Bachelor of Science in Medical Technology.

Diana Amador-Toro is the current NJ District Director (DD) in FDA’s Office of Regulatory Affairs (ORA), overseeing 90 FDA employees over three offices and having responsibility over 4,600 FDA-regulated firms.  Prior to assuming the DD position in November 2008, Ms. Amado-Toro served six years as an FDA Director of Investigations in NJ plus four years as the Science Branch Director in the San Juan District Office, where she was responsible for formulating operating policies and procedures that included sample analyses and laboratory research and investigations at the San Juan District Laboratory.

Ms. Amador-Toro received her B.S. degree from the University of Puerto Rico in 1982, and joined the FDA as an Investigator in the Newark District Office.  In 1990, she transferred to San Juan as a Drug Specialist and subsequently become the first Pre-Approval Manager for both Drugs and Devices in the field.  She has over 27 years of field experience in investigations and compliance activities, has contributed to ICH and FDA Guidance documents and has conducted international GMP training in Argentina and the UK.

Ms. Amador-Toro is a USDA graduate of the Executive Potential Management Program and throughout her career has been recognized for her leadership, contributions and accomplishments in Compliance, Investigations and Laboratory activities with numerous agency honor awards, including the Commissioner’s Special Citation and FDA’s highest award, the Award of Merit.

PresentationFD&C Divison Offerings

Donald C. Singer is a Senior member of ASQ and a former Chair of the Food, Drug and Cosmetic Division.  As a Certified Specialist Microbiologist (NRCM), Don is Global Lead Manager, Microbiology R&D for GlaxoSmithKline.  He has been a Malcolm Baldrige Award Examiner and a former National Director, Divisions, on the ASQ Board.

He has been a member of the USP Microbiology & Sterility Assurance Committee of Experts since 2000.  Don has convened and taught an ongoing series of industry workshops at American Society for Microbiology General Meetings.

He has been a member of ASQ since 1982, is a Certified Pharmaceutical GMP Professional and has a Six Sigma Green Belt.  Don is an active representative for ASQ in the USP Convention, with over 30 years of research, quality control, quality assurance, and laboratory management experience in the pharmaceutical, cosmetic, food, beverage, hospital products and medical device industries.

He is an author and editor of books about the laboratory, including two Quality Press books, and he has been an adjunct professor of Biopharmaceutical QC Microbiology at the University of Maryland Baltimore Campus.

Irwin Silverstein is a consultant specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients.

Irwin was formerly the Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products for 17 years. He has worked since 1991 with the International Pharmaceutical Excipients Council (IPEC) developing guidance documents for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration to educate the agency and public on these documents.

Irwin has been the VP and Chief Operating Officer of IPEA since 2001 and was instrumental in achieving ANSI accreditation for the Excipient GMP Conformance Certification program.

He has been consulting to both the pharmaceutical and excipient ingredient industries since 2000.

Bob Seltzer is a Regulatory Compliance Manager with GlaxoSmithKline Consumer Healthcare R&D, which he joined in July 2009.  He was a Compliance Manager-GMP in Schering-Plough’s Global Quality Audits and Compliance corporate group 2003 – 2009, and he has more than 22 years in R&D, Process Development, and Quality Assurance/Compliance in pharmaceuticals and medical devices.

Bob created and was the driving force behind the ASQ Certified Pharmaceutical GMP Professional (CPGP), which ASQ adopted on May 1, 2008 as its fifteenth certification; and he holds CPGP Certificate No. 1.  He is ASQ Food Drug & Cosmetic Division’s (FD&C’s) Northeast Pharmaceutical GMP/Quality Conference Chair and is the immediate past FD&C Pharmaceutical Program Chair.

He holds an MS in Biochemistry and BS/BA in Chem Engineering and Biochemistry, all from Rutgers, New Brunswick.  He is a Senior Member of ASQ and a Certified Quality Auditor, Quality Engineer, Manager of Quality/ Organizational Excellence, Certified Biomedical Auditor, and CPGP.  He has been active in the Parenteral Drug Association Metro Chapter, chairing its Chapter Day Symposium the past five years.  Bob is an avid trainer and frequent speaker in healthcare industry CGMP Compliance.