West Coast Chapter Meetings and Events

Agenda

• 6:00 PM Registration and Networking Hour
• 7:00 PM Dinner
• 7:45 PM Announcements
• 8:00 PM Presentation & Discussion
• 9:30 PM Closing

Topic Summary

WCC PDA invites you to attend the opening session of the 2012 Professional Dinner Meeting Series.  Neil Wilkinson, NSF-DBA, will present a general overview of the International Conference on Harmonization (ICH) Quality Guideline Q10, Pharmaceutical Quality System (PQS).  Neil’s presentation will help to address some questions from the audience, such as:

• What are some implementation strategies for Q10?
• What are the Quality Management System expectations from Q10?
• What is new/different from the Quality Systems currently in place by most pharmaceutical companies?
• How have companies changed their Quality Manual to emphasize Q10?
• How are CAPA effectiveness checks being done and tracked to tie into continuous improvement?
• What are recent 483/FDA inspection comments regarding areas of Q10?
• What are the Regulatory and Lifecycle approaches for Q10?

Following the presentation, the audience will be invited to participate in an exchange of thoughts and perspective on the Q10 guidlines. 

Presenter Biography

Neil Wilkinson, NSF-DBA, is a chemist with over 30 years of broad experience within the pharmaceutical industry across a range of dosage forms and APIs.  He has held senior roles in laboratory, quality management, manufacturing, and supplier assurance, including Senior Director of Global Quality for AstraZeneca.  Neil has wide experience within international roles covering the US, EU, and Asia.  He has acted as a Qualified Person (QP) in Europe, for which he remains eligible. 

Neil joined NSF-DBA in 2008 and is a Partner based in their US office.  He is actively involved in NSF-DBA’s education/training programs and consulting/audit services. Neil has extensive experience working with industry trade associations, having been the chair of European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing GMP Group and a member of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) Technical Group.  Neil was the EFPIA topic leader within the ICH Expert working group that generated the ICH Q10 (Pharmaceutical Quality System) Guideline and was involved in defining the ICH Quality Vision for ICH Q8/9/10.  He remains actively involved with PDA/ISPE activities to facilitate Q10 implementation, including the recent FDA/EMA Q10 conferences.

NEW REGISTRATION POLICY
Registration fees for 2012 have changed.  Please note that Pre-registration is $70.00 (Credit/Cash/Check); Walk-ins/At Door $75.00 (Cash/Check Only). There is a $15.00 Discount for Government Employees and Students (discount applied at the door).

Submit registration requests via e-mail to rsvp@wccpda.org with "WCC PDA January 2012 Dinner RSVP" as the subject line. Indicate name and company affiliation for each registrant. If you provided your information, a seat will be reserved for you. 

Reserved seating is limited to the first 100 registrants! It is strongly encouraged that you register in advance to ensure seating at this event, and to allow us to provide an accurate head count for meals.

Payment Options

WCC PDA uses PayPal^® to process all credit card payments. Access PayPal directly from the chapter website at www.wccpda.org (click the "Events" button and scroll down to the PayPal link). You do not need a PayPal account to use the online payment service and there is no additional fee for registrants. For check payments, you can use the PayPal service or make paper checks payable to "WCC-PDA." If you experience difficulty with the PayPal link, contact the webmaster.

Payment via PayPal ®

Please RSVP too, as described above.

WCC PDA meeting attendees can now use PayPal® to process all credit card payments.  You do not need a PayPal account to use the online payment service and there is no additional fee.  You may access PayPal directly via the attached link or complete a credit card form to sign and bring the night of the event. 

Important Notes: Make sure that the quantity in the shopping cart is correct and don't use the back button on your browser. Some employers may block access to PayPal. In this case, you may have to register from home or we can do it for you if you complete a credit card form. Once you have entered the number of attendees for whom you are paying, click the "Proceed to Checkout" button. Do not use the "Continue Shopping" button. A charge from PayPal will appear on your credit card bill. If you experience difficulty with this link, contact the webmaster.

Cancellation Policy!

Dinner seating is reserved and confirmed in advance. We regret that no refunds can be offered for non-attendance. If a registrant is unable to attend, substitutions are welcome.

Sponsorship:

Sponsors have the opportunity to showcase their company, network with the attendees, and get mention in the evening's announcements and color brochure. We have a reception sponsor for the January 2012 meeting, but If your company is interested in sponsoring an upcoming event, please let us know!

"ICH Quality Guideline Q10, Pharmaceutical Quality System"