An Overview of the American Society for Qualitys Food, Drug and - PowerPoint PPT Presentation

An Overview of the American Society for Quality’s Food, Drug and Cosmetic Division presented by Eduardo Heidelberg Past Chair FDC Division

How It All Started § In 1960, the Food and Allied Industries Division formed. § In 1974, this division merged with the Drug and Cosmetic Technical Committee to create what is now the Food, Drug and Cosmetic Division.

FDC Vision & Mission • Our Vision To be recognized as the resource of choice for quality systems and leadership development in Food, Drug and Cosmetic regulated industries • Our Mission To increase member value by conducting activities and involving members to fulfill the Division ’ s Vision

What does this mean? n We provide resources for organizational excellence and quality leadership development to those working within regulated food, food additive, dietary supplement, pharmaceutical, OTC, cosmetic, personal care and allied industries.

Who makes up Our Membership? n Quality professionals n Regulatory affairs and compliance professionals n Scientists n Engineers and manufacturing professionals n Auditors and consultants

What Our Membership Looks Like § Representation - 61 Countries - 50 States including Washington, DC, Puerto Rico and the U.S. Virgin Islands § Total membership - 5194 - 44 members in the Puerto Rico Section § Member types - Majority are Regular and Senior - 42 Fellows among our ranks § Roles & Responsibilities - More than 50% hold management responsibility - Most hold at least one ASQ Certification and belong to more than 2 divisions

ASQ Region Map

What is the FDC Division? § Professional Development § Conferences/ Workshops/ Seminars § Certification § Publications/ Newsletters/ Website

Professional Development § Focus your professional development resources through industry-specific § Conferences § Workshops § Seminars § Webinars § Certifications § Publications

FDC Conferences § West Coast § Ofelia Barretto § East Coast § Eduardo Heidelberg § Midwest § June Morita § Southeast § Rick Perlman § Long Island § Rick Calabrese § Canada (Breakfast Conference) § Andrew M. Gould § Looking to add biannual East and West Coast Conferences § Regional Conferences every other year

Past Conference Presentations § Packaging and Labelling-Regulatory Compliance and Expectations § Legal Issues – Before, During and After Inspections § FDA Drug Inspection Update: International Inspection Program/Amendments to cGMP Regulations § Toxicological Risk Assessment in Pharmaceutical Cross-Contamination and Impurities Issues § Corporate Challenges to the Quality Unit

Past Workshops § "GMP Series: Quality and Productivity in a GMP Microbiology Lab - Survival in a "More with Less" Environment“ § "Manufacturing and Quality Control of Standard Microbial Cultures for Use in Food, Drug and Cosmetic Industries

ASQ Certifications § Mark of excellence § Demonstrates that the certified individual has the knowledge to assure quality of products and services § An investment in your career and in the future of your employer. § “ASQ believes the integrity of the exams is a key factor in why companies rely on them as a foundation for training and assessing their quality staff.” J.W. Moran and P. C. La Londe, Quality Progress, 33 , 4, (2000).

ASQ Certifications and the FDC Division § The FDC Division has been instrumental in its efforts to establish new certifications § HACCP Auditor - CHA § Certified Pharmaceutical GMP Professional - CPGP

CHA Certification § Originally began as the CQA-HACCP. § The Hazard Analysis and Critical Control Point was an add-on to the Certified Quality Auditor certification § HACCP has evolved over the years. As a result, the ASQ Certified HACCP Auditor exam has also evolved and now stands on its own. § The Body of Knowledge has been updated to include the principles of management systems auditing and the analytical tools of quality assurance. § There are now 1209 CHA ’ s

Certified Pharmaceutical GMP Professional § Certification approved in 2008 § 322 newly certified CPG Professionals § 105 of these are in the FD&C Division § Next Steps: § The CPGP handbook and exam (in development).

Recent Publications The Certified HACCP Auditor Handbook was n developed by the FDC Division to assist the certification candidate in preparing for the CHA examination. Pharmaceutical Certification Book – Coming Soon! n Past Articles in “FDC GLOBAL VIEW” , the Division n Newsletter “ U.S. Food Safety: Home-Grown Problems Abound ” n “ The Philosophy of Quality: At the Intersection of n Service and Supervision ” “ The FDA Takes Action Against Unapproved Drugs ” n “ Food Safety in a Global Marketplace ” n “ Childhood Lead Exposure ” n “ Cosmetic Good Manufacturing Practice Guidelines ” n

Industry Information n Gain valuable information via FDC newsletter “FDC GLOBAL VIEW” n Visit FDC Division web site for links to industry resources http://asq.org/fdc/ n Division and Committee Contact Information n Conference and Workshop Information n Newsletters n Discussion Boards n Career Services

Networking n Expand your network of quality professionals in your field n Includes professionals from the food, pharmaceuticals, cosmetics, dietary supplements and related products industries.

Thank you for your time! Any Questions?