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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
Food, Drug & Cosmetic Division
Our Focus: Member Value
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?
Food, Drug & Cosmetic Division
Our Focus: Member Value
ALWAYS FOCUS ON DELIVERING MEMBER
VALUE BY:
• Striving for diversity
–Through People:
• We welcome all comers!
–Through Industry:
• Foods
• Dietary Supplements
• Pharmaceuticals
• Cosmetics
• Cosmeceuticals
Food, Drug & Cosmetic Division
Our Focus: Member Value
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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
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
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
Food, Drug & Cosmetic Division
Our Focus: Member Value
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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
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
Food, Drug & Cosmetic Division
Our Focus: Member Value
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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
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
Food, Drug & Cosmetic Division
Our Focus: Member Value
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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
Annual Regional Conferences:
•Southeast Conference
–Annual conference on Compliance
in FDA regulated industries.
–Great FDA support.
–Held in North Carolina
Food, Drug & Cosmetic Division
Our Focus: Member Value
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.
– 2010 Conference Honored Former FDA Lawyer,
Stephen McNamara for his years of support
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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
Food, Drug & Cosmetic Division
Our Focus: Member Value
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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:
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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.
Food, Drug & Cosmetic Division
Our Focus: Member Value
• 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
Food, Drug & Cosmetic Division
Our Focus: Member Value
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 :
Food, Drug & Cosmetic Division
Our Focus: Member Value
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:
Food, Drug & Cosmetic Division
Our Focus: Member Value
ALWAYS FOCUS ON DELIVERING MEMBER VALUE.
Thank you!
Questions, Comments?
Food, Drug & Cosmetic Division
Our Focus: Member Value