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

An Overview

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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

• rganizational 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

n

The Certified HACCP Auditor Handbook was developed by the FDC Division to assist the certification candidate in preparing for the CHA examination.

n

Pharmaceutical Certification Book – Coming Soon!

n

Past Articles in “FDC GLOBAL VIEW” , the Division Newsletter

n

“U.S. Food Safety: Home-Grown Problems Abound”

n

“The Philosophy of Quality: At the Intersection of Service and Supervision”

n

“The FDA Takes Action Against Unapproved Drugs”

n

“Food Safety in a Global Marketplace”

n

“Childhood Lead Exposure”

n

“Cosmetic Good Manufacturing Practice Guidelines”

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?