1. The PDA Southern California Chapter is Proud to Present:
“Q3 2013 Educational Program Event”
Presented by: Neil Wilkinson
Managing Partner, NSF-DBA, part of NSF Health Sciences Division
On the Subject of
“Implementing ICH Q10:
Improving Business Performance –
How to make it happen”
September 26th
, 2013 (Thursday Afternoon)
Registration/Networking: 3:00-4:00PM
Presentation/Q&A: 4:00-5:30 PM
Networking Resumes: 5:30PM
Dinner: 6:00PM
(Food & Beverages Provided at All Venues)
Three locations to choose from:
Amgen
Conference Center
(Thousand Oaks)
DPR
Facility
(Orange County)
Genentech/Roche
Facility
(Oceanside)

2. Information on Topic & Speaker: “Implementing
ICH Q10: Improving Business Performance – How
to make it happen!”
Presentation Overview:
Bio:
Neil Wilkinson
Managing Partner
NSF-DBA
ICH Q10 Pharmaceutical Quality System was finalized in 2008 and has become a regulatory
expectation in the countries and regions that adopt ICH guidelines, including the US, EU,
Japan and others. Implementation across the Pharma/Biotech sector remains patchy, both
within individual firms, and across the sector overall. This presentation will discuss the
current regulatory agency views on Q10, some of the challenges firms face in
implementation, share some novel approaches taken to break down functional silos, and
how to provide the business case to executive management. Neil Wilkinson of NSF-DBA
was a member of the ICH Q10 Expert Work Group who wrote the guideline and has seen a
range of approaches to implementation.
Neil Wilkinson has over 25 years experience within the
Pharmaceutical Industry gained via a range of Quality, Compliance,
Manufacturing, New Products and Supply Chain related roles. His
experience includes senior roles within both Site and Corporate
organizations and wide experiences of working in different
countries, such as EU, USA, Japan, China, India and others. He
acted as an EU Qualified Person (QP) for many years. Mr.
Wilkinson has represented the Pharmaceutical Industry via the
major trade associations in the EU (Efpia) and the USA (PhRMA) as
well as within the ICH process, where he was an industry topic
lead for the ICH Q10 (Pharmaceutical Quality System) Expert Work
Group. Mr. Wilkinson is a Chemist, holding a post-graduate
qualification in Pharmaceutical Quality. He remains eligible to act
as an EU Qualified Person. His most recent industry role was as
Senior Director of Global Quality in AstraZeneca. He has wide
experience of educating, auditing and consultancy in
Pharmaceutical Quality, Development and Manufacture/Supply.

3. All those who wish to attend must register.
ATTENDEES - REGISTER ONLINE OR USING THE REGISTRATION FORM:
http://www.pda.org/GlobalEventCalendarandRegistration/Chapters/Southern-California/PDA-
Southern-California-Chapter-Educationl-Event-Implementing-ICH-Q10.aspx
Or visit PDA website: www.pda.org/southerncalifornia and click “Upcoming
Events”
EXHIBITORS – FOR EXHIBIT REGISTRATION SEE LAST PAGE
For more information - contact Bill Nichols at (760) 639-1741 OR John
Holmgren at (714) 246-5562.
Early Registration Fee submitted on or before September 24th
*:
$ 40 Member (food & beverages provided)
$ 65 Non–Member (food & beverages provided)
$ 30 Government employee
$ 15 Full-time Student
No Charge for Genentech Employees (Oceanside only)
No Charge for DPR Employees (Newport Beach only)
No Charge for Amgen Employee (Thousand Oaks only)
All Amgen, DPR and Genentech/Roche employees must register.
*Late registration is available for an additional $10 fee. Complete the
form and Mail (if paying by check) or Go to PDA online (link above if
paying by credit card). For all check payments, please mail to the address
listed below made payable to the “Southern California Chapter of the
PDA”. For all credit card payments, fax it to PDA Treasurer, Bill Nichols at
(760) 509-4910.
PDA Members: in order to register as a PDA member, you will need to set
up a PDA member login with username and password (unless you’ve
already done it).

4. If you are not able to register online, you can register using the attendee
registration form on the next page. Please fax your registration with credit
card payment to: Bill Nichols at (760) 509-4910. If paying by check, submit
the check with the completed registration form to the address below.
Mail Check Payments Payable to:
Southern California Chapter of the PDA
ATTN: Bill Nichols
2110 Camino Cantera
Vista, CA 92084
Cancellations: Money is nonrefundable if cancellations are made after
Friday September 20th, 2013
EXHIBITOR OPPORTUNITY FEES ARE NOTED ON LAST PAGE. Note, one
attendee is included with Exhibitor Fees; additional exhibitor attendees
must register using regular registration form on next page.

5. ATTENDEE REGISTRATION FORM – CHECK OR CREDIT CARD
Attendee Name: __________________________________________________
Title: ____________________________________________________
Company: ____________________________________________________
Business Address: _______________________________________________
City/Zip: __________________________________________
Business Phone: (____) _______________Fax Number (____) ______________
E-mail Address: __________________________________________________
Event Location: ___ Amgen Facility, Thousand Oaks
___ Genentech / Roche Facility, Oceanside
___ DPR, Newport Beach
Attendee Early
Registration Fee: ___$ 40 Member (ID #___________________)
Submitted on or ___$ 65 Non-Member
before Sept 24th ___$ 30 Government employee
___$ 15 Student
___ Free (Amgen T.O., DPR Newport or Genentech/Roche Oceanside)
Attendee Late
Registration or ___$ 50 Member (ID #___________________)
Walk-In Fee: ___$ 75 Non-Member
Submitted on ___$ 40 Government employee
Sept. 25th
or ___$ 25 Student
day of event ___ Free (Amgen T.O., DPR Newport or Genentech/Roche Oceanside)
For Visa, MC, or American Express Payments, fax COMPLETED registration form to PDA, Bill Nichols at
(760) 509-4910. Incomplete forms will not be processed. [PLEASE PRINT CLEARLY]
__________________________________ Total to be charged $______.____
Name as it appears on card
___________________________________________________________
Credit Card Billing address, City, State, Zip Code
________________________________________________________________
Card number Expiration Date
________________________________________________________________
Signature Date

6. Event Locations & Directions
September 26th
2013 (Afternoon)
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

7. September 26th
2013 (Afternoon)
DPR Facility
4665 MacArthur Court, Suite 100
Newport Beach, CA 92660
(949) 955-3771
Directions to DPR
Traveling Southbound on 405 Freeway Traveling Northbound on 405 Freeway
Take the MacArthur Blvd South exit, EXIT 8
Turn left onto MacArthur Blvd.
Turn left onto Campus Dr
Turn right onto MacArthur Ct
Turn right to stay on MacArthur Ct
4665 MACARTHUR CT is on the left.
Suite 100 is on the first floor.
Take the Jamboree Rd exit, EXIT 7
Turn left onto Jamboree Rd
Turn right onto Campus Dr
Turn left onto MacArthur Ct
4665 MACARTHUR CT is on the left.
Suite 100 is on the first floor.
DPR Facility 4665 MacArthur Court, Ste.100, Newport Beach

8. September 26th
2013 (Afternoon)
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

9. EXHIBITOR REGISTRATION FORM
Exhibitor Name: _________________________________________________
Title: ____________________________________________________
Company: ____________________________________________________
Business Address: _______________________________________________
City/Zip: __________________________________________
Business Phone: (____) _______________Fax Number (____) ______________
E-mail Address: __________________________________________________
Event Location: ___ Amgen Facility, Thousand Oaks
___ Genentech / Roche Facility, Oceanside
___ DPR Facility , Newport Beach
Exhibitor: ___$ 300 for one location - includes attendance for one attendee, additional
attendees must use regular registration form
___$ 500 for two locations includes attendance for one attendee at each
location, additional attendees must use register using registration form
___$700 for three locations includes attendance for one attendee at each
location, additional attendees must use register using registration form
Mail Check Payments Payable to: Southern California Chapter of the PDA
ATTN: Bill Nichols
2110 Camino Cantera
Vista, CA 92084
For Visa, MC, or American Express Payments, fax COMPLETED registration form to PDA, Bill Nichols at
(760) 509-4910. Incomplete forms will not be processed. [PLEASE PRINT CLEARLY]
__________________________________ Total to be charged $______.____
Name as it appears on card
___________________________________________________________
Credit Card Billing address, City, State, Zip Code
________________________________________________________________
Card number Expiration Date
________________________________________________________________
Signature Date