PDA Supply Chain Security in the Pharmaceutical Industry.pdf

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The PDA Southern California Chapter is Proud to Present:
The PDA Southern “Insight California from Chapter the Experts” is Proud to Present:
The PDA Southern “Insight California from Chapter the Experts” is Proud to Present:
“Insight Steven Wolfgang from the Experts”
Steven Wolfgang
Compliance)
Steven Wolfgang
Compliance)
Kevin Siver
Compliance)
(Director of Supplier Kevin Quality Siver Management, Amgen )
(Director of Supplier Quality Management, Amgen )
Lucy
Kevin
Medeiros
Siver
Cabral
(Director of Supplier Quality Management, Amgen )
(Head of Global Supplier Lucy Medeiros Quality Management, Cabral Genentech/Roche)
(Head of Global Supplier Lucy Quality Management, Genentech/Roche)
Gerard
Medeiros
Pearce
Cabral
(Head of Global Supplier Quality Management, Genentech/Roche)
(Executive Gerard Vice President, Pearce SQA Services )
(Executive Gerard Vice President, Pearce SQA Services )
(FDA Acting Associate Director, Office of Drug Security, Integrity and Recalls (ODSIR) Office of
(FDA Acting Associate Director, Office of Drug Security, Integrity and Recalls (ODSIR) Office of
(FDA Acting Associate Director, Office of Drug Security, Integrity and Recalls (ODSIR) Office of
On the Subject of
(Executive Vice President, SQA Services )
On the Subject of
On the Subject of
“Supply Chain Security in the Pharmaceutical
Industry”
August 30 th “Supply Chain Security in the Pharmaceutical
“Supply Chain Security in the Pharmaceutical
Industry”
Industry”
, 2011 (Tuesday Morning)
August 30
Registration/Networking with
Continental Breakfast: 8:00-9:00AM
Presentations: 9:00-Noon
Three locations to choose from:
Amgen
Hilton Hotel Irvine
Genentech/Roche
Conference Center
Orange County Airport
Facility
th , 2011 (Tuesday Morning)
August 30
Registration/Networking with
Continental Breakfast: 8:00-9:00AM
Presentations: 9:00-Noon
Three locations to choose from:
Amgen
Hilton Hotel Irvine
Genentech/Roche
th , 2011 (Tuesday Morning)
Registration/Networking with
The PDA Southern California Chapter is Proud to Present:
Continental “Insight Breakfast: from the 8:00-9:00AM Experts”
Presentations: 9:00-Noon
Steven Wolfgang
Three locations to choose from:
(FDA Acting Associate Director, Office of Drug Security, Integrity and Recalls (ODSIR) Office of
Conference (Thousand Amgen Oaks) Center
Orange Hilton (Orange Compliance)
County Hotel County) Irvine Airport
Genentech/Roche
(Oceanside) Facility
Conference (Thousand Oaks) Center
Orange (Orange County) Kevin County Siver Airport
(Oceanside) Facility
Webcast (Thousand / Live Oaks) Feed Available - Contact (Orange County) Bill Nichols (info on registration form)
(Director of Supplier Quality Management, Amgen (Oceanside) )
Webcast / Live Feed Available - Contact Bill Nichols (info on registration form)
Webcast / Live Feed Available Lucy - Medeiros Contact Bill Nichols Cabral (info on registration form)
(Head of Global Supplier Sponsored Quality Management, By: Genentech/Roche)
Sponsored By:
Gerard Sponsored Pearce By:
(Executive Vice President, SQA Services )
On the Subject of
“Supply Chain Security in the Pharmaceutical
Industry”
th

quality operation by connecting a
president and head of operations w
r, and is closely involved in shaping
ortune 500 clients .
Information on Topic & Speakers:
Presentation Overview:
Exhibitors:
Exhibitors:
This chapter event will provide insight to the current issues the pharmaceutical industry is facing in
securing its supply chain and informs you about the current and future challenges. Steven Wolfgang
from FDA will open the session from Washington DC by sharing FDA’s latest thinking on this subject.
The Information event will be on hosted Topic in three & Speakers: Southern California locations with a simulcast between venues. At
the Genentech/ Roche facility in Oceanside, Lucy Cabral will introduce a risk-based approach to
managing Presentation suppliers Overview: and contract manufacturers including management oversight levels at contractor
sites during the supplier/contractor life cycle. At the Amgen conference center in Thousand
Oaks, This chapter Kevin Siver event will will present provide on insight behalf to of the Martin current VanTrieste issues the on pharmaceutical the need for action industry in facing is facing the in
criminal securing activities its supply in chain the supply and informs chain by you use about of best the practices, current and technology, future challenges. collaboration Steven and Wolfgang management
from FDA involvement. will open the session At the Irvine/Airport from Washington Hilton DC Hotel by in sharing Orange FDA’s County, latest Gerard thinking Pearce on this will subject. provide
an introduction to Rx-360 and present the scope and current accomplishments of their audit
program The event pilot. will be hosted in three Southern California locations with a simulcast between venues. At
the Genentech/ Roche facility in Oceanside, Lucy Cabral will introduce a risk-based approach to
Steven managing Wolfgang, suppliers PhD and contract is Acting manufacturers Associate Director including for Risk management Science, Intelligence oversight levels and Prioritization
at contracin
tor the sites CDER during Office the of supplier/contractor Compliance’s new life Office cycle. of At Drug the Security, Amgen conference Integrity and center Recalls in Thousand (ODSIR).
This Oaks, office Kevin was Siver formed will present this year on to behalf address of Martin all drug VanTrieste supply chain on the related need issues for action within in FDA. facing In the his
criminal 6.5 years activities at FDA, in Dr. the Wolfgang supply chain has been by use involved of best in practices, various activities technology, aimed collaboration at promoting and security management
and integrity involvement. throughout At the the drug Irvine/Airport component Hilton and finished Hotel in drug Orange supply County, chains. Gerard These Pearce activities will pro- invide
clude an writing introduction guidance to Rx-360 for incorporation and present of Physical the scope / Chemical and current Identifiers accomplishments into drug products, of their partici- audit
pating program in pilot. research activities for the development of analytical screening tools, and identifying gaps in
excipient monographs that are currently being implemented via the USP compendial modernization
initiative. Steven Wolfgang, PhD is Acting Associate Director for Risk Science, Intelligence and Prioritization
Prior in the to CDER joining Office FDA, of Steve Compliance’s spent 15 years new Office as a technical of Drug Security, support chemist Integrity with and the Recalls API and (ODSIR). excipient
manufacturing This office was division formed this of a year large to address generic all drug drug manufacturing supply chain firm. related He issues has a within Ph.D. FDA. in Inorganic In his
Chemistry 6.5 years at from FDA, the Dr. City Wolfgang University has of been New involved York and in a various B.A. in activities Chemistry aimed from at Queens promoting College security (also
in and New integrity York City). throughout the drug component and finished drug supply chains. These activities include
writing guidance for incorporation of Physical / Chemical Identifiers into drug products, participating
in research activities for the development of analytical screening tools, and identifying gaps in
excipient monographs that are currently being implemented via the USP compendial modernization
initiative.
Prior to joining FDA, Steve spent 15 years as a technical support chemist with the API and excipient
manufacturing division of a large generic drug manufacturing firm. He has a Ph.D. in Inorganic
Chemistry from the City University of New York and a B.A. in Chemistry from Queens College (also
in New York City).

Kevin Siver, PhD is a director of Quality at Amgen Inc. He is responsible for Supplier Quality
Management, Quality Systems and Compliance for Amgen’s External Quality organization. External
Quality provides oversight for Amgen’s contract manufacturers and raw material suppliers. Kevin has
been involved with various professional and trade organizations, including the Parenteral Drug
Association (PDA), PhRMA, AAPS and ACS. Kevin worked with PhRMA’s Stability Technical
Working Group to provide industry feedback to ICH Q3A. Kevin has over 25 years in the pharmaceutical
industry in both R&D and Quality. Prior to joining Amgen, he was with Pfizer as Director, Quality
at their Kalamazoo Operations. He came to Pfizer through Pharmacia, where he served as the Global
Stability Manager and was part of their 21 CFR Part 11 Program Office. He started his career in 1986
with Wyeth-Ayerst after obtaining his PhD in Medicinal Chemistry from the University of Florida.
Lucy Medeiros Cabral is Head of Global Supplier Quality Management and US Distribution Quality.
Lucy has over seventeen years of management experience at Genentech, Inc. in the Quality
Assurance, Compliance, and Quality Control groups. She has extensive experience managing
commercial and clinical contract manufacturers and material suppliers operating in the US, Europe,
and Asia. Lucy holds a Bachelor of Arts in Biology and she is an expert in auditing raw material
suppliers.
Currently Lucy is the Head of Supplier Quality Management (Senior Director), for the Roche Pharma
worldwide responsible for the management of materials (chemicals and components). The team is
responsible for qualifying and monitoring Roche suppliers worldwide of clinical and commercial
material for biologics and small molecule products. Lucy is also responsible for Distribution Quality
that oversees all distribution centers and third party contractors located in the US region.
Gerard Pearce is a quality and supply chain expert with over 20 years experience in combining the
disciplines of quality, technology and supply management. His expertise spans a variety of industries
and geographies, including Asia-Pacific, Western Europe, and North America. For the last ten years,
Gerard has focused on defining the infrastructure that provides managed supplier quality programs
for numerous global leaders in the fields of pharmaceuticals, medical devices, electronics, aerospace,
consumer goods and more. Central to this infrastructure is the technology required for effectively
running a global supplier quality operation by connecting all stakeholders in the supply chain.
Currently the executive vice president and head of operations with SQA, Gerard is a regular industry
commentator and contributor, and is closely involved in shaping and implementing the global supplier
quality strategy for SQA’s Fortune 500 clients.

About Rx-360: Rx-360 is a non-profit consortium involving industry associations such as PDA,
pharmaceutical companies, raw material supplier companies, and audit service provider companies.
This consortium has been established to share market surveillance, develop operating standards,
create an independent supplier audit function to improve the efficiency, oversight and accountability
of the pharmaceutical supply chain, and advance technologies for detection and prevention of
material adulteration. This Deming-based approach promises the benefits of monitoring of quality and
security in the supply chain, standardization of best practices across industry, and cost reduction in
the supply chain. Participants are invited to learn more about the consortium by visiting www.Rx-
360.org.
All those who wish to attend must register.
Register online, on or before Aug. 26, using the link below:
Click Here
Or visit PDA website: www.pda.org/southerncalifornia
and click “Upcoming Events”
Cancellations: Money is nonrefundable if cancellations are made after Friday, August 26th.
For more information - contact Bill Nichols at (760) 639-1741 OR John Holmgren at (714)
246-5562.
Registration Fee: $ 35 Member
$ 50 Non - Member
$ 25 Government employee
$ 25 Full-time Student
No Charge for Amgen Employee (Thousand Oaks only)
No Charge for Genentech/Roche Employee (Oceanside only)
All Amgen and Genentech/Roche employees must register.

Amgen
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
(805) 447-1000
Directions to Amgen
Traveling Southbound on 101 Freeway Traveling Northbound on 405 and 101 Freeway
Traveling 101 S (towards Los Angeles)
Exit 47A, Borchard Rd. / Rancho Conejo Blvd.
Turn Left on Borchard Rd / Rancho Conejo Blvd
Continue to follow Rancho Conejo Blvd.
Turn Right on Hillcrest Drive
Make a Right into Visitor Building # 34 Parking Lot
Visitors take shuttle to Conference Center
Take 405 N to 101 N (towards Ventura)
Exit 47A, Rancho Conejo Blvd.
Turn Right on Rancho Conejo Blvd
Turn Right on Hillcrest Drive
Make a Right into Visitor Building # 34 Parking Lot
Visitors take shuttle to Conference Center
Amgen One Amgen Center Drive, Thousand Oaks

Hilton Hotel Irvine/Orange County Airport
18800 MacArthur Blvd.
Irvine, CA 92612
(949) 833-9999
Directions to the Hilton Hotel – Irvine / Orange County Airport
Traveling Southbound on 405 Freeway Traveling Northbound on 405 Freeway
Exit Macarthur
Turn Left on Macarthur
Hotel is on left (corner of Macarthur and Douglas)
Exit Macarthur
Turn Left on Macarthur
Hotel is on left (corner of Macarthur and Douglas)
Hilton Hotel – Irvine / Orange County Airport 18800 MacArthur Road, Irvine

Genentech/Roche Oceanside Facility
1 Antibody Way
Oceanside, CA 92056
(760) 231-2440
Directions to Genentech/Roche
Traveling Southbound on 5 Freeway Traveling Northbound on 5 Freeway
Exit for Oceanside Blvd (exit 52)
Turn Left onto Oceanside Blvd.
Turn Left onto Corporate Centre Drive
Turn Right on Antibody Way
Turn Left (destination on the right
Exit 51b to merge onto CA-78E towards Escondido
Take El Camino Real / County Highway S11exit
Turn Left onto El Camino Real
Turn Right onto Oceanside Blvd.
Turn Left onto Corporate Centre Drive
Turn Right on Antibody Way
Turn Left (destination on the right)
Genentech/Roche Facility 1 Antibody Way, Oceanside