food, drug, and cosmetic division -

FOOD, DRUG, AND

COSMETIC DIVISION

OUR FOCUS: MEMBER VALUE

2010-2011

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.– 1972 - supported founding of the

Biomedical Division.

–Close collaboration continues.

–Benefits members and non-members.

Food, Drug & Cosmetic Division

Our Focus: Member Value

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



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?



ALWAYS FOCUS ON DELIVERING MEMBER

VALUE BY:

• Striving for diversity

–Through People:

• We welcome all comers!

–Through Industry:

• Foods

• Dietary Supplements

• Pharmaceuticals

• Cosmetics

• Cosmeceuticals




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.




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.



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



• 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.



• 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.





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.

Why become certified?

“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).

Some specifics: Certification:

• 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.



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.




(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




• 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.



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




• 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.




•Southeast Conference

–Annual conference on Compliance

in FDA regulated industries.

–Great FDA support.

–Held in North Carolina




• 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.

– 2010 Conference Honored Former FDA Lawyer,

Stephen McNamara for his years of support



• 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



• 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.



• 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





• 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

• 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



• 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.



• Standards work:

– Many years of emphasis on Food Safety.

– In 2009 - 2010

• Worked to have ISO 22000 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 22000 family

of standards.



• 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



• 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:

[email protected]



• 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.



• 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



• 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 2011.

• Form discussion groups nationwide on cosmetic quality.



• Elected Officers (2010-2011):

–Chair - James Loseke

–Chair Elect - Rosemarie Christopher

–Vice Chair - Elena Kalbach

–Treasurer - Ed Arling

–Secretary- Cathelene Compton

–Immediate Past Chair – Eduardo

Heidelberg



Returning for 2010 - 2011

–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 :

[email protected]



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:

[email protected]



ALWAYS FOCUS ON DELIVERING MEMBER VALUE.

Thank you!

Questions, Comments?



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