So cal pda_event 9-26-2013

291 views
251 views

Published on

Published in: Business, Economy & Finance
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
291
On SlideShare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
2
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

So cal pda_event 9-26-2013

  1. 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. 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. 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 $10 fee. Complete the form and Mail (if paying by check) or Go to PDA online (link above if paying by credit card). For all check payments, please mail to the address listed below made payable to the “Southern California Chapter of the PDA”. For all credit card payments, fax it to PDA Treasurer, Bill Nichols at (760) 509-4910. PDA Members: in order to register as a PDA member, you will need to set up a PDA member login with username and password (unless you’ve already done it).
  4. 4. If you are not able to register online, you can register using the attendee registration form on the next page. Please fax your registration with credit card payment to: Bill Nichols at (760) 509-4910. If paying by check, submit the check with the completed registration form to the address below. Mail Check Payments Payable to: Southern California Chapter of the PDA ATTN: Bill Nichols 2110 Camino Cantera Vista, CA 92084 Cancellations: Money is nonrefundable if cancellations are made after Friday September 20th, 2013 EXHIBITOR OPPORTUNITY FEES ARE NOTED ON LAST PAGE. Note, one attendee is included with Exhibitor Fees; additional exhibitor attendees must register using regular registration form on next page.
  5. 5. ATTENDEE REGISTRATION FORM – CHECK OR CREDIT CARD Attendee Name: __________________________________________________ Title: ____________________________________________________ Company: ____________________________________________________ Business Address: _______________________________________________ City/Zip: __________________________________________ Business Phone: (____) _______________Fax Number (____) ______________ E-mail Address: __________________________________________________ Event Location: ___ Amgen Facility, Thousand Oaks ___ Genentech / Roche Facility, Oceanside ___ DPR, Newport Beach Attendee Early Registration Fee: ___$ 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. 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. 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. 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. 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

×