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IPEC-Americas News
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IPEC-Americas, Inc., 1655 North Fort Myer Drive, Suite 700, Arlington, VA 22209
www.ipecamericas.org, email: [email protected], Tel: 703-875-2127
IPEC-AMERICAS NEWS
INSIDE THIS ISSUE
General Update Report September 2011……....1&2
IPEC-Americas Files Written Testimony for Senate
HELP Committee……………………………………….….…2-5
IPEC-Americas to Launch Professional E-News
Brief………………………………………………………………..….5
Member News………………………………………….………..6
IPEC-Americas Webinar Training…………………...6&7
FDA News…………………………………………………....…….7
More FDA News…………………………………………………8
IPEA Workshops……………………………………………8&9
Food Industry Forum: Educational Program…9-11
Developing Pharmaceutical Products for
Controlled Drug Delivery Workshop……..……11&12
2012 IPEC-Americas Committee/Working Group
Meeting Schedule………………………………………..12-14
Other Important Industry Meetings ……..………….15
September 2011
General Update Report September 2011 During the quarterly meetings of IPEC-
Americas committee and working
groups, it has been customary in recent
years to set aside one evening to bring
members of the different committees
together to report to each other
concerning their progress and to share
news. During the 3rd quarter meetings
which took place September 26-29, the
General Update session was held on
Wednesday, September 28.
Representatives of 22 IPEC-Americas
members were in attendance, along with
those of 2 prospective member
companies, plus staff and counsel.
The 2012 committee meeting schedule
was announced and is reprinted below.
This was followed by a report on the
September 14 Senate Health, Education,
Labor & Pensions (HELP)Committee
hearing in which IPEC-Americas
participated and provided written
testimony which also is printed below.
An update on the status of ICH Q3D,
which deals with metal impurities, also
was discussed as this is being followed
closely by Compendial Review Committee
members.
This discussion was followed by reports on
the status of:
ExcipientFest Asia, which will be held
in Beijing, China, September 2012;
EXCiPACT; and
Page 2
IPEC-Americas News
As a result of the September 14 public
hearing held by the U.S. Senate Health,
Education, Labor and Pensions (HELP)
Committee on Securing the
Pharmaceutical Supply Chain, IPEC-
Americas was invited by the
Committee to file written testimony for the
record. This was submitted September 22
and is reprinted below for IPEC-Americas
member information:
IPEC-Americas Files Written Testimony for Senate HELP Committee
The NSF 363 Excipient GMP
standard which is expected to be
adopted and published during the
second quarter of 2012
A corporate overview of NSF International
and its history also was provided, along
with a summary of its activities and
standard-setting capabilities throughout
the world. Following completion of NSF
363, other cooperation with NSF
International also could be possible.
Mentioned were: an IPEC-Americas
regional member’s meeting which could
be held at the NSF campus in Ann Arbor,
Michigan; a training program partnership;
and joint ventures between NSF and IPEA
for EXCiPACT/ANSI audits.
Other matters discussed were issues
related to FDA’s Inactive Ingredient
Database (IID) which have been affecting
ANDAs and the agency’s Substance
Registration System. A meeting at FDA is
planned with Office of Generic Drug
officials and possibly others through the
Regulatory Affairs Committee.
The status of FDA’s request for IPEC
members to participate in development of
an excipient spectral library to aid FDA
inspectors was the next topic discussed.
This remains an ongoing project whose
purpose is to improve global supply chain
security through an ability to identify
materials that are different from their
special reference standards so they can be
readily “flagged” for further investigation.
The last topic discussed was a planned
IPEC-FDA QbD Excipient Workshop to be
held at FDA’s White Oak, MD facility in early
December. Its purpose would be to help
agency scientists and inspectors better
understand how excipients themselves are
manufactured and produced for different
purposes and differences between their
manufacture for specific uses, e.g. their
variability.
More information on all matters is available
through IPEC-Americas committees. If any
are of interest, maybe you should get
involved!
Page 3 IPEC-Americas News
Chairman Tom Harkin, Ranking Member
Michael Enzi, and Members of the
Senate Health, Education, Labor and
Pensions Committee: As the Chair of
the International Pharmaceutical
Excipients Council-Americas (IPEC-
Americas), I, on behalf of IPEC-
Americas, appreciate this opportunity
to submit written testimony and thank
you for the leadership you have
displayed in addressing the crucial
need to secure the pharmaceutical
supply chain.
IPEC-Americas helped create a
Federation of four independent regional
industry associations, with the others
headquartered in Europe (IPEC Europe),
Japan (JPEC) and China (IPEC China).
Our goal is to ensure current Good
Manufacturing Practices (cGMP) to meet
high quality standards for excipients,
more commonly known as the inactive
pharmaceutical ingredients. IPEC
Federation members include over 300
national and multinational excipient
makers and users, including chemical
companies, pharmaceutical
manufacturers, and food companies.
These members include over 60 U.S.
companies that belong to IPEC-
Americas and other members of the
Global IPEC Federation.
Each regional association focuses its
attention on the applicable law,
regulations, science, and business
practices of its region of the globe.
The four associations work together on
excipient safety and public health issues,
in connection with international trade
matters, and to achieve harmonization of
regulatory standards and pharmacopoeial
monographs.
We are also the premier source for
regulatory and guidance documents
critical to the excipient industry; offer
training and consulting services to ensure
regulatory compliance worldwide; and
provide awards to encourage research and
education in excipients. Our guidance
documents have been adopted and relied
upon by various regulatory bodies and
standard setting organizations, including
the Food and Drug Administration (FDA)
and the United States Pharmacopeia.
While attention to the pharmaceutical
supply chain has generally been focused
on active pharmaceutical ingredients
(APIs), we were pleased to note an interest
in the supply chain of pharmaceutical
excipients in your September 14, 2011
hearing. As was noted by Chairman
Harkin and Deborah Autor, Deputy
Commissioner for Global Regulatory
Operations and Policy at the FDA, it was
the death of 100 people from an
adulterating excipient, diethylene glycol,
that led to the enactment of the Federal
Food, Drug and Cosmetics Act (FFDCA) in
1938. Yet, as was also noted, 570 people
have died from the same substance in the
past 20 years worldwide. As recently as
2009, more than 80 infants died from
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IPEC-Americas News
adulterated teething syrup
contaminated by diethylene glycol in
Nigeria. These are no small threats to
the United States as the
pharmaceutical supply chain becomes
more and more globalized.
Commissioner Autor noted a number
of safeguards with which IPEC agrees
and which should apply to both APIs
and excipients: enacting legislation
that gives the FDA the authority to
refuse the importation of drugs into
the U.S. if a facility does not allow
itself to be inspected; requiring proof
that a product is "good" to enter the
U.S., rather than FDA having to find
something wrong; leveling the playing
field by providing requirements and
incentives for all companies to follow
the rules; and ensuring that
manufacturers have adequate control
over the supply chain.
IPEC fully supports each and every one
of these goals and has drafted
legislation to do so. Our proposal
would direct the FDA to recognize
accredited third-party auditors to
certify that manufacturers, distributors
and importers of excipients meet
safety standards that are in
compliance with the FFDCA. The
legislation would also call for the
establishment of qualification
standards for third-party auditors and
certifiers who have the necessary
expertise and training in auditing
techniques.
IPEC has been working with FDA to
develop appropriate third-party audit
requirements for excipients. This effort
is integral to IPEC's 20-year effort to
develop and maintain high industry
standards for excipient safety and quality.
To give real teeth to the FDA, IPEC’s
proposal would mandate that individuals
or companies not be allowed to import
into the United States a drug or excipient
used in the manufacture of a drug if the
product or ingredient was manufactured
or produced outside of the U.S. by an
entity which has not been certified by the
FDA or by an FDA-recognized third-party
auditor.
IPEC is a "coalition of the willing" --
member companies who want to ensure
the safety and efficacy of excipients and
have put mechanisms in place to do so.
However, there are actors out there who
are not as willing and present a serious
threat to the security of the excipients
supply chain. Our proposal would require
that companies follow cGMP and
therefore prove that the excipient
products are "good." This in turn would
level the playing field, requiring that all
companies be compliant, rewarding good
products with entry into the U.S. and
turning away those that are not.
Third-party auditing and certification also
addresses the need for manufacturers to
have adequate control over their suppliers
and the supply chain, which, as
Commissioner Autor noted, is
Page 5 IPEC-Americas News
necessary because the FDA simply does
not have the resources to monitor all
manufacturers, users, and distributors
of excipients. Third-party certification,
which would be funded by companies
wishing to import into the U.S., would
provide those resources in a
mechanism that is revenue-neutral to
the federal government.
In short, the proposal would provide
the same powers to FDA that Congress
recently provided the agency as it
relates to contaminated food, but
that it still lacks for drugs: the power to
keep contaminated or adulterated
products or ingredients from reaching
the pharmaceutical production process.
We ask that the Committee and the full
Congress adopt our proposal for a third-
party auditing and certification process to
ensure the safety of U.S. citizens.
IPEC-Americas to Launch Professional E-News Brief
IPEC-Americas is partnering with Multi-
View (a digital media delivery service)
to provide a professionally edited e-
news brief for our association members
and industry professionals! The
newsletter will issue two times a
month, and will include headlines,
short abstracts and hyperlinks of
published articles and stories gathered
from over 14,500 media outlets, along
with updates and information about
current IPEC projects and activities.
Useful member tools include a mobile
app for subscribers using an iPhone,
Android or Blackberry device for access
to all news and links found in the
MultiBrief; rss feeds and archiving
ability.
Opportunities to advertise in the e-
newsletter also will be available. Please
contact Kim Beals, IPEC-Americas
Executive Director, if your company
would like to learn more about
advertising choices.
Look for our e-newsbrief in your email
in-box during the next month!
Page 6
IPEC-Americas News
IPEC-Americas Webinar Training
Member News
As reported in the PHARMA Capsules section of Pharmaceutical Technology, September
2011
“Catalent Announces Cold-Chain Expansions
Catalent Pharma Solution’s Clinical Supply Services division has expanded its global cold-
chain supply operations in the United States, United Kingdom, and Germany, to meet
increasing demands for global supply. The expansions will be implemented in all major
areas of Catalent’s cold-chain storage and distribution, including 2 to 8 C and – 80 C
capabilities. In some instances, the expansion will more than triple existing capacity for
storage and distribution. Catalent expects that the cold-chain expansion at its European
sites in Bolton, UK, and Schorndorf, Germany, will be completed by the end of 2011.”
Register Now! IPEC-Americas has 3 educational webinars remaining in the 2011 series! Even if you missed the first one on September 20
th (Quality Agreements), you can still register for all
four. The link to the Quality Agreement recording will be forwarded to you after you register.
Tuesday, October 25: Good Manufacturing Practices (GMP) Global Regulations - How they are applied to excipients and GMP for excipients, Understand and Review various global guidelines, IPEC GMP, ICHQ7, WHO GMPs & GDPs ANSI and EXCiPACT highlights. Presenter: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials Tuesday, November 8: Excipient Auditing
How IPEC Guidance Documents and the Excipient Information Package (EIP) Relate to the Supplier Audit Process
Presenter: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials
Tuesday, December 20: 3rd Party GMP Certification Preparation and maintenance - IPEA, EXCiPACT review
Page 7 IPEC-Americas News
FDA News
September 16 – Dr. Moheb Nasr resigns
as Director of CDER’s Office of New Drug
Quality Assessment to accept position at
GSK.
On September 2nd, Office of
Pharmaceutical Science Director Helen
Winkle circulated an announcement
relating to Dr. Nasr’s retirement following
a 22 year career at FDA, the last 8 as
ONDQA Director within OPS.
As noted in Ms. Winkle’s
announcement…”Moheb’s career
accomplishments are many.
He is internationally recognized as a
leader in pharmaceutical product quality
and drug regulation by both government
and industry. He championed and
articulated the vision of Quality by Design
(QbD), risk-based regulatory systems and
other FDA pharmaceutical quality
initiatives.”
It is hoped that in his new position at
GlaxoSmithKline, where he will serve as
Vice President for Regulatory CMC
Strategy, Dr. Nasr will continue to share
his insights with IPEC members
concerning QbD and other critical
regulatory matters. He will be sorely
missed at FDA.
Presenters: Dale's Carter, Global Quality Director, Silica, JM Huber, Engineered Materials and Dr. Irwin B. Silverstein, Vice President and Chief Operating Officer, IPEA, and President of IBS Consulting in Quality LLC All webinars will take place from 11:00 AM – 1:00 PM Eastern Time and utilize the WebEx training platform. Registration Fees:
$275 IPEC-Americas Member Company Employees
$500 Non Members
One session price: $75 IPEC-Americas Member Company Employees $150 Non Members REGISTER: www.IPEC-Events.com Information to join each webinar will be emailed a few days prior to each one with the call-in numbers.
Page 8
IPEC-Americas News
IPEA Workshops
More FDA News
FDA is announcing the availability of a
revised guidance entitled “Marketed
Unapproved Drugs--Compliance Policy
Guide Sec. 440.100, Marketed New Drugs
Without Approved NDAs or ANDAs” (CPG
440.100). CPG 440.100 describes how
FDA intends to exercise its enforcement
discretion with regard to drug products
marketed in the United States that do not
have required FDA approval for
marketing. This CPG (440.100) has been
revised to state that the enforcement
priorities and potential exercise of
enforcement discretion discussed in the
CPG apply only to unapproved new drug
products that are being commercially
used or sold as of September 19,
2011. All unapproved new drugs
introduced onto the market after that
date are subject to immediate
enforcement action at any time, without
prior notice and without regard to the
enforcement priorities set forth in the
CPG.
http://www.gpo.gov/fdsys/pkg/FR-2011-09-
21/pdf/2011-24316.pdf FDA Notice of
compliance policy guide
Comments can be submitted to FDA at
anytime.
Enforcement priorities and potential
exercise of enforcement discretion apply
only to products sold or marketed as of
September 19, 2011.
3 Day Excipient Auditing Workshop in
Arlington, VA (DC Metropolitan area)
October 25-27, 2011
8 spaces left! This popular workshop
offers participants training in the
assessment of excipient manufacturer
conformance to appropriate GMP
requirements.
The workshop contains exercises to hone
observation skills, including participation
in a hands-on mock excipient GMP audit.
The last workshop sold-out quickly so be
sure to register early. The workshop
leaders are Drs Sidney Goode and Irwin
Silverstein.
Registration is now open and available on
line. Class size is limited to 20 for better
participation.
Go to: http://www.ipeainc.com/auditing-
workshop
Page 9 IPEC-Americas News
Workshop Schedule:
Tuesday 10/25/2011 Registration first
day 8:00-8:30am
Tuesday-Thursday Workshop Sessions
8:30am-4:30pm plus a networking
cocktail session.
For questions about the Arlington
workshop:
contact Valeria Stewart at IPEA, Inc. at
703-351-5266 or email:[email protected]
2 ½ Day IPEA Excipient Auditing
Workshop (no mock audit) October 6-8,
2011 in conjunction with FDA – Xavier
Global Outsourcing Conference in
Cincinnati, OH, October 2 – 5, 2011
Registration is available for this
workshop. Please go to:
http://medxu.com/goc/registration-2/
About the Xavier Conference:
• Co-Sponsored by the FDA
• Bringing pharma (i.e., pharma,
biotech, generics, OTC) together
with contract organizations to not
only address the dysfunction in
contract relationships, but also to
identify what can be done together
to increase overall patient safety –
including supply chain security
• The October agenda has a heavy
focus on suppliers, but also
provides an understanding of how
to conduct effective audits that
meet FDA and Global expectations.
For information on the Xavier
Conference, including conference
registration go to:
http://medxu.com/goc/ or contact Sue
Bensman at 513-745-3396
FOOD INDUSTRY FORUM NOVEMBER 3 & 4
LA CONCHA RESORT SAN JUAN, PUERTO RICO WWW.FOODINDUSTRYFORUMPR.COM
THURSDAY, NOVEMBER 3, 2011. Block #1 (8:00 am – 9:45 am) Concurrent PRODUCT DEVELOPMENT AND MARKET TRENDS - Session Director: Angel Custodio, PhD, UPR, Utuado
“Development and Innovation: What to consider when launching a new product?” -Irvis Pagán, IYP Food
“Food Processing Principles” - Damaris Del Castillo, Goya de PR, Inc.
“Challenges in artificial flavor development of tropical fruits”-María de Lourdes Plaza, PhD, UPR, Mayagüez
“The Sensory Evaluation Perspective of Product Development” - Fernando J. Pérez, PhD, UPR, Mayagüez
“Nanotechnology in the Food Industry” – Sindia Rivera, PhD, UPR Mayaguez
KEY NOTE SPEAKER - “The latest trends in the Bread Industry: New Ingredients and Techniques” - Jean François Celuzza, Technical Baking Center Manager, SAF Products
Page 10
IPEC-Americas News
Block #2 (8:00 am – 9:45 am) Concurrent PREREQUISITE PROGRAMS IN THE FOOD INDUSTRY Session Director: Luz Damaris Rosario, Control Director Suiza Dairy Co.
“GMPS, Training and Record Keeping and Traceability”- Luz Damaris Rosario, Quality Control Director Suiza Dairy
“Designing and Implementing an Effective Cleaning and Disinfection Program” - Pedro Watlington, General
Manager, ECOLAB
“Designing and Implementing an Effective Pest Control Program in the Food Industry” - Hugo Avila, Director
Technical Director, Oliver Exterminating
“Risk Management and Product Recall” - Rafael Del Valle, Sr. Vice President, Marsh & Saldaña, Inc.
Block #3 FDA and USDA REGULATIONS - Session Director: María de Lourdes Rivera, BS Chem, ASQ CQA & CHA, FSP
“Current Compliance and Regulatory Issues for FDA Regulated Food Industries” - Maridalia Torres, FDA SJ District Director
“USDA Regulatory Inspection” - Olga Morales, USDA and Food Safety and Inspection Service
“Current Compliance and Regulatory Issues for Regulated Food Industry in Puerto Rico” - Mayra Toro, MPH,
Auxiliary Secretary of Health Department
“ACLASS on Food Safety Modernization Act” - Roger Muse, Director Sales and Marketing, ANSI-ASQ National Accreditation Board
Block #4 LABELING, PACKAGING AND DISTRIBUTION Session Director: Celia R. Quiñones, MS, MS, UPR, Utuado
“General Requirements of Food Labeling” - Julie Reiling, PhD, Product Development Consultant, The Food Processing Center, University of Nebraska, Lincoln
“Food Labels and Nutritional Facts: Food Analysis Requirements” S. Suzanne Nielsen, PhD, Professor and Head of Department of Food Science, Purdue University
“Allergens: Why Should We Worry?” Edna Negrón, PhD, Head, Food Science and Technology Program, UPR, Mayagüez
“Understanding the Supply Chain: Insight from Experience” - Gloria Irizarri-Toledo, Senior Manager 1, Food Safety & Health, Wal-Mart PR, Inc.
KEY NOTE SPEAKER: “Food Packaging Interaction” - Joseph H. Hotchkiss, PhD “The Guru of Active Packaging” Director for Packaging Innovation and Sustainability Michigan State University Friday, November 4, 2011. Block #1 (8:00 am – 9:45 am) Concurrent ENTREPRENEURSHIP IN THE FOOD INDUSTRY - Session Director: Fernando J. Pérez, PhD, UPR, Mayagüez
“Bona Fide Agriculture: Benefits and Responsibilities” - Miguel Santiago Assistant Secretary for Innovation and Agricultural Commercialization, Agricultural Department, FIDA
“Promoting the Agro-Industry” - Anthony Cardona Business Development Official, PRIDCO
“Law 73: Export Incentives” - Ángel Muñoz Suarez, Compañía de Comercio y Exportación
“Financing Options” - Luis Nuñez, Small Business Administration, Puerto Rico District Office
“Business Incubation for the Food Industry” - Hector Carlo, MBA, Managing Director for ViTEC² KEY NOTE SPEAKER - Thomas F. Farb, Executive Director - Puerto Rico Science, Technology & Research Trust Block#2 (8:00 am – 9:45 am) Concurrent TOPICS AND TRENDS OF FOOD SERVICE - Session Director: Angel Custodio, PhD, Departments of Agricultural Technology & Natural Sciences, UPR, Utuado
“Trends in Cooking: Sous Vide, molecular gastronomy” - Angel Custodio, PhD, Departments of Agricultural Technology & Natural Sciences, UPR, Utuado
Page 11 IPEC-Americas News
“Molecular Gastronomy: Culinary art and Chemistry” - Ram Lamba, PhD, Professor and Member of Bureau IUPAC
“Solving Common Problems in the Kitchen: Back to Basics” - Shirley O Corriher, Writer and Biochemist
“Sustainable fresh vegetables production; a local perspective” - Josefina Arce, PhD, UPR, Río Pierdras Block #3 FOOD SAFETY AND QUALITY - Session Director: María de Lourdes Rivera, BS Chem, ASQ CQA & CHA
“Safe Quality Foods 1000 & 2000” - Lynette Orellana, PhD, UPR, Mayagüez
“HACCP Auditor Certification” - Jim Loseke, Chair of the ASQ Food, Drug and Cosmetic Division and Director of Quality for Sargento
“Compendia testing standards role in the assurance of food ingredients Quality and Safety” - Carla Mejia, PhD, USP Food Ingredients
“Advances in Analytical Tests for Food Safety” - Brenda Cruz Ríos, MS Mass Spectrometry, Waters Corporation
“Food Safety and Quality Management Systems: Baldrige Performance Excellence Program” - Mrs. Carmen Marti, Executive Director of SBTDC
Block #4 SUCCESFUL FOOD INDUSTRY ENTREPRENEURS: - THE ETHICS AND INTEGRITY OF THE BUSINESS Session Director: Maria Felix, Industrial Division VP, Able Sales Company
Marvel Specialties - Lic. Alberto Bacó, President
Holsum of Puerto Rico - Ramón Calderón, President
Caribbean Produce Exchange, Inc. - Gualberto Rodríguez III, President
Los Cidrines, Inc. - Manuel Cidre, President, KEY NOTE SPEAKER: Felipe Perez, El Mesón Sandwiches
Speakers and Topics Pulmonary drug metabolism, clearance, and absorption Staffan Edsbacker, AstraZeneca, Sweden Low cost inhalation technologies designed for use in the developing world Anthony Hickey, University of North Carolina, U.S.A. Overcoming lung clearance mechanisms for controlled release drug delivery Hugh Smyth, University of Texas, U.S.A. Controlled transport for pulmonary drug delivery Jennifer Fiegel, University of Iowa, U.S.A. Excipient selection, biomaterials, and biocompatibility in pulmonary drug delivery Paul Myrdal/Aliyah Sheth, University of Arizona, U.S.A.
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IPEC-Americas News
Particle engineering technologies for pulmonary drug delivery Cory Berkland, University of Kansas, U.S.A. In vitro performance testing for pulmonary drug delivery Jason McConville, University of Texas, U.S.A. Regulatory issues and challenges relating to pulmonary products Gur Jai Pal Singh, Axar Pharmaceuticals, U.S.A. Pulmonary Drug Delivery: future prospects based on lessons learned John Patton, Dance Pharmaceuticals, U.S.A.
Take advantage of a world class opportunity to learn from the best and network with colleagues. Early registration deadline is September 9. To learn more and register, visit: www.controlledreleasesociety.org/meetings/Pages/DevelopingPharmaceuticalProducts.aspx Sponsorships Sponsorship opportunities are available as well. Contact Deborah Woodard at +1.651.994.3817 or [email protected] to become a workshop sponsor. Register early and save money Early registration ends September 9, 2011. Registration is $995 on or before that date, $1,095 after. To register for this workshop, visit the AAPS and CRS workshop website. This workshop is cosponsored by AAPS and CRS and will be held immediately prior to the 2011 AAPS Annual Meeting.
2012 IPEC-Americas Committee/Working Group Meeting Schedule
All meetings will take place at the office of
Buchanan Ingersoll & Rooney
1700 K Street, N.W., Washington, D.C. 20006
February
Tuesday, February 21 Executive Committee 11:00am – 5:00pm
Page 13 IPEC-Americas News
Wednesday, February 22
Validation Working Group 8:00am – 12:00pm Quality by Design 8:15am – 12:00pm EIP Working Group 9:00am – 12:00pm Lunch – 12:00pm
Excipient Composition 1:00pm – 5:00pm Thursday, February 23 Good Manufacturing Practices 8:15am – 12:00pm Lunch – 12:00pm Excipient Qualification 1:00pm – 5:00pm General Update 5:30pm – 7:30pm Friday, February 24 Compendial Review 8:00am – 11:30pm
Lunch – 12:00pm Regulatory Affairs/Safety 1:00pm – 5:00pm
May
Monday, May 14 Executive Committee 11:00am – 5:00pm Tuesday, May 15
Validation Working Group 8:00am – 12:00pm Quality by Design 8:15am – 12:00pm EIP Working Group 9:00am – 12:00pm Lunch – 12:00pm
Excipient Composition 1:00pm – 5:00pm Wednesday, May 16 Good Manufacturing Practices 8:15am – 12:00pm Lunch – 12:00pm Excipient Qualification 1:00pm – 5:00pm General Update 5:30pm – 7:30pm Thursday, May 17 Compendial Review 8:15am – 12:00pm
Lunch – 12:00pm Regulatory Affairs/Safety 1:00pm – 5:00pm
Page 14
IPEC-Americas News
September
Monday, September 24 Executive Committee 11:00am – 5:00pm Tuesday, September 25
Validation Working Group 8:00am – 12:00pm Quality by Design 8:15am – 12:00pm
EIP Working Group 9:00am – 12:00pm Lunch – 12:00pm
Excipient Composition 1:00pm – 5:00pm Wednesday, September 26 Good Manufacturing Practices 8:15am – 12:00pm Lunch – 12:00pm Excipient Qualification 1:00pm – 5:00pm General Update 5:30pm – 7:30pm Thursday, September 27 Compendial Review 8:15am – 12:00pm
Lunch – 12:00pm Regulatory Affairs/Safety 1:00pm – 5:00pm
December Monday, December 3 Executive Committee 11:00am – 5:00pm Tuesday, December 4
Validation Working Group 8:00am – 12:00pm Quality by Design 8:15am – 12:00pm EIP Working Group 9:00am – 12:00pm Lunch – 12:00pm
Excipient Composition 1:00pm – 5:00pm Wednesday, December 5 Good Manufacturing Practices 8:15am – 12:00pm Lunch – 12:00pm Excipient Qualification 1:00pm – 5:00pm Board of Trustees 5:30pm – 8:00pm Thursday, December 6 Compendial Review 8:15am – 12:00pm
Lunch – 12:00pm Regulatory Affairs/Safety 1:00pm – 5:00pm
Page 15 IPEC-Americas News
Other Important Industry Meetings
October 6-7
CHPA’s 2011 OTC Product Quality & Operations Workshop
Hyatt Regency Bethesda
Bethesda, Maryland
Register: www.chpa-info.org
October 11-12
3rd Annual Great Lakes cGMP & Regulatory Science Forum
University of Illinois at Chicago (UIC Forum) College of Pharmacy
Chicago, IL
Register: http://www.regonline.com/register/checkin.aspx?eventid=932206
October 22-23
AAPS Workshop – Pharmaceutical Stability Scientific and Regulatory Considerations
for Global Drug Development and Commercialization
Walter E. Washington Convention Center
Washington, D.C.
Register: www.aapspharmaceutica.com/stability
October 23-27
2011 AAPS Annual Meeting and Exposition
Walter E. Washington Convention Center
Washington, D.C.
Register: www.aapspharmaceutica.com/annualmeeting
November 14-17
2011 Eastern Analytical Symposium & Exposition
Garden State Exhibit Center
Somerset, New Jersey
Register: www.eas.org
