FOOD, DRUG, AND COSMETIC DIVISION

Transcription

1 FOOD, DRUG, AND COSMETIC DIVISION OUR FOCUS: MEMBER VALUE

2 Some History: Food and Allied Industries Division Founded in 1960 by William Golomski past ASQ President and Honorary Member. The Division later became the Food, Drug and Cosmetic Division supported founding of the Biomedical Division. Close collaboration continues. Benefits members and non-members.

3 The FD&C Division Vision: To be recognized as the resource of choice for quality systems and leadership in Food, Drug and Cosmetic regulated industries

4 The FD&C Division Mission: To increase member value by conducting activities and involving members to fulfill the Division's Vision. So, how do we implement our Mission?

5 ALWAYS FOCUS ON DELIVERING MEMBER VALUE BY: Striving for diversity Through People: We welcome all comers! Through Industry: Foods Dietary Supplements Pharmaceuticals Cosmetics Cosmeceuticals

6 ALWAYS FOCUS ON DELIVERING MEMBER VALUE BY: Mentoring leaders and emphasizing succession planning One of the first member units to develop a true succession plan. Helps to grow a loyal, cohesive and committed team.

7 ALWAYS FOCUS ON DELIVERING MEMBER VALUE BY: Holding member leaders accountable and expecting them to perform to measurable goals. PROOF: The Division has achieved the McDermond award every year for the last decade.

8 ALWAYS FOCUS ON DELIVERING MEMBER VALUE BY: Planning for the future: Annual two day Strategic Meeting which includes: Development of an extensive Business Plan, supported by a realistic budget. Emphasis on Short term and Long term (five year) Strategic Plans. Review is held at the World Conference on Quality and Improvement

9 Overview of member services: Certification development and support: HACCP Auditor. Pharmaceutical GMP Professional. Division Newsletter FD&C Control: Updates on Division activities and related topics Now in greener electronic format Division Web Site: Web Site: Delivered through the ASQ Website.

10 Overview (continued): Support of Standards development Emphasis in Food Safety regulations and guidance. Four Annual Regional Conferences In harmonization with US FDA and Industry. Every year for many years. Discussion Groups Enhance member knowledge. Cost effective FD&C Scholarship Program Established over 10 years ago.

11 Some specifics: Certification: Mark of excellence Why become certified? 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).

12 HACCP Auditor Certification (CHA) Sponsored by the Division starting in 1998 More than 600 professionals have been certified. Verifies understanding of the audit principles of a HACCP-based (or process-safety) system. Widely used in the Food, Pharmaceutical and Cosmetics industries. Certified HACCP Auditor Handbook supports candidates for certification. written by FD&C Division subject matter experts (SMEs). Translated to Spanish by ASQ Section 1500 Puerto Rico.

13 Certified Pharmaceutical GMP Professional (CPGP) Sponsored by the Division starting in 2005 Body of Knowledge includes: Worldwide laws, regulations, standards, Guidances, etc. GMP-compliant and noncompliant methods, activities, results, and reports, and how to prevent or correct noncompliance.

14 Certified Pharmaceutical GMP Professional (CPGP) Exam Preparation Material: Practice exam now available through ASQ Series of articles based on CPGP Body of Knowledge now published in Journal of GxP Compliance and Journal of Validation Technology Study questions: Currently being developed Handbook: In progress

15 Certified Pharmaceutical GMP Professional This Certification: Raises the GMP compliance bar to a higher level. Supports internal Continuous Quality Improvement (CQI) programs Includes sector-specific applied knowledge. Is a source of professional and personal pride. Enhances a professional's credibility and standing.

16 Annual Regional Conferences: Northeast Conference Annual conference on Compliance in the Regulated Pharmaceutical industries, Great FDA support. A superb example of Co-Sponsorship ASQ Princeton Section and the FD&C Division Provides timely, relevant compliance information

17 Annual Regional Conferences: Midwest Conference Annual conference on Compliance in regulated industries. Support and cooperation by the Chicago District Director FDA. Typical program topics Devices, Pharmaceuticals, Processes, Validation, Risk management, Statistics, Six sigma.

18 Annual Regional Conferences: Southeast Conference Annual conference on Compliance in FDA regulated industries. Great FDA support. Held in North Carolina

19 Annual Regional Conferences: West Coast Conference Annual conference targeting Food, Drug, and Medical Device/Biomedical Industries. Focused on Dietary Supplements and Food Safety Supported by FDA, U.S Customs, FTC, NIH, California Department of Public Health, Industry and others Conference Honored Former FDA Lawyer, Stephen McNamara for his years of support

20 The Regional Councilor Program Outreach program for Division and ASQ members interested in FDA activity Councilors serve as liaisons between local sections and FD&C Division Regions represented in the US, Puerto Rico, South America, Canada and Japan Councilors provide information by writing articles on topics of interest to division members for newsletter and website

21 The Regional Councilor Program Quality Standards and Regulations Plans for 2011: Draft new CAPA Guideline Draft new standard for developing drugs Establishing program for review and comment on changes to FDA/Health Canada regulations.

22 Division Discussion Groups Division leadership commitment Nationwide and local to each ASQ Region Geographic in orientation helps Division/Section Collaboration Currently in Illinois and California Being developed in Minnesota, Pennsylvania, and Massachusetts Evaluating potential interest for developing group in New Jersey

23 Division Discussion Groups Member values fostered: Industry Specific Education drugs, foods, dietary supplements covered; cosmetics pending) Re-certification Units (ASQ certifications) Networking Leadership training New Member retention / Non member recruitment Low cost for each event - Surplus shared with Section

24 Examples: Midwest Discussion Group Formed in 2008, average attendance: 35 Host locations: Anderson Packaging, Promega Corporation, Alberto Culver. Long range plan: Quarterly discussion group meetings Additional host facilities

25 Examples: West Coast Discussion Group: Formed in 2006, average attendance: 32 Host locations: Golden State Foods, WatsonPharma, Gilead, B.Braun, Baxter Bioscience, Pharmatek Long range Plan: Quarterly meetings in 6 areas of S.CA. Monthly Steering Committee Meetings A 1/2 Day Quality Conference.

26 Standards work: Many years of emphasis on Food Safety. In Worked to have ISO approved as benchmark standard by the Global Food Safety Initiative (GFSI). Presentation of a certification system that should meet GFSI certification and Wal-Mart (US) food safety requirements. Danish Standards proposed to form an ISO subcommittee to manage the ISO family of standards.

27 FDC Control Our Premier Newsletter Started in 1960 with the founding of the Food and Allied Industries Division Has become a tangible member service for over 50 years. Past Editor Dr. James Kohnen, ASQ Fellow, has kept this tradition alive for over 30 years Followed by Editor Michael Gregor switched to all-electronic format Current Editor Adam Brock expanded length of newsletter

28 FDC Control Our Premier Newsletter It helps fulfill the vision of our founders and the needs of our members. Name to change in 2011, based on members input Exceptional information source on the ASQ FD&C Division Website. Improves communications to our members. Looking for your input: Contact Editor Adam Brock:

29 FD&C Division Scholarship Program Established over 10 years ago. Two Scholarships offered annually Founders 4 year, $1,000 undergraduate scholarship For members of the FD&C Division or their families Nine Founders scholarships awarded since 1999 Lavoisier Graduate scholarship for members of the FD&C Division Two Founders Scholarships awarded in 2008 Future improvements Increase publicity, better communication, (Website). Redesign the application to allow it to be filled on-line.

30 FD&C Division Scholarship Program In 2010 both the Founders scholarship and the Lavoisier scholarship were awarded This was the first presentation of the Lavoisier scholarship

31 Moving forwards in Cosmetics Focus has been on Food and Drugs for many years. We want to better serve our members in the Cosmetics industry. Current Initiative "Cosmetics - Guidelines on Good Manufacturing Practices" Article compares to 21 CFR 211 (pharmaceuticals). Posted on the Division Website. Future Initiatives Form a network of cosmetic industry professionals. Cosmetic/cosmeceutical conference in Form discussion groups nationwide on cosmetic quality.

32 Elected Officers ( ): Chair - James Loseke Chair Elect - Rosemarie Christopher Vice Chair - Elena Kalbach Treasurer - Ed Arling Secretary- Cathelene Compton Immediate Past Chair Eduardo Heidelberg

33 Returning for Volunteer Chair: Position previously held by Diane Kulisek After a period of inactivity was reinstated this year To learn more about volunteer activities contact Alice Krumenaker : a.krumenaker@gmail.com

34 ALWAYS FOCUS ON DELIVERING MEMBER VALUE. If you have a professional interest in Foods, Pharmaceuticals, Cosmetics or related industries JOIN US! For more information, contact Division Chair Jim Loseke: jim.loseke@sargento.com

35 ALWAYS FOCUS ON DELIVERING MEMBER VALUE. Thank you! Questions, Comments?