November Dinner Meeting and Tour of Wyeth BioPharma Facility

Event Topics/Titles:
PDA Technical Report 29: “Points to Consider for Cleaning Validation”
New England PDA Chapter Elections

Speaker Bios:
John Hyde has presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, cleaning and cleaning validation principles and practices, FDA compliance strategies, and control systems design for manufacturing processes. He has published ten articles on these subjects. Mr. Hyde served as a member of the PDA Subcommittee for Biopharmaceutical Cleaning Validation and in this capacity he contributed two chapters to a book on the subject. Mr. Hyde serves on the board of the Society of Bioprocess Professionals (SBP) and he is a regular speaker on conferences presented by SBP, ISPE, PharmaConference, IVT, Microrite and other professional societies. He holds Bachelors degrees in Food Science and Business Administration, and a Masters degree in Food Engineering, all from the Ohio State University.

Richard Jushchyshyn directs the activities of the North Wales, PA office supporting clients in the Tri-State region of Pennsylvania and the Research Triangle area of North Carolina in the design, commissioning and qualification of biopharmaceutical process and utility systems. Since joining Hyde, Richard has provided consultation and project management services in support of validation master planning, CIP and COP systems design, commissioning, qualification, cleaning validation and cleaning remediation efforts for many of the major biopharmaceutical companies in his territory

Kathleen Kendrick has years of experience in the biopharmaceutical commercial and clinical manufacturing as well as validation industry.  At Wyeth BioPharma, she serves as an internal consultant for manufacturing cleaning procedures and development, areas of experimental design and validation, new product cleanability assessment and technical problem solving.  She holds a Bachelor of Science degree in Biology and a Masters degree in Biology and Biotechnology.

Event Abstract:
Facility Tour of Wyeth BioPharma manufacturing facility in Andover, MA, followed by a dinner meeting which will focus on Cleaning Validation. Richard Jushchyshyn will present John Hyde’s talk on “TR29: Initiating Good Cleaning Practices” where he will outline the qualifications, procedures and practical information needed to establish strong Clean-In-Place and Clean-Out-of-Place programs. Kathleen Kendrick will discuss “Maintaining Good Cleaning Practices” which entails sample processing, cleaning monitoring, revalidation assessment and routine system maintenance.

NEPDA Chapter Officer Elections: The NEPDA officers serve 2-year terms. The President-Elect automatically becomes Chapter President. The positions for election include President-Elect, Secretary, Treasurer and 2 Member-at-Large positions. Per PDA guidance documents, the nominees are to have at least 1 year of service to the chapter at the planning / business meetings and be PDA members. The NEPDA Nominating Committee (Myron Dittmer and Bruce Rotker co-chairs) proposes a slate of officers to the NEPDA Board of Directors. Upon approval, this slate is proposed to the NEPDA members. A ballet will go out with the meeting notice and ballets will be available at the meeting. The ballet will have space for write-in candidates. Only PDA members may vote.

Tour Location:
1 Burtt Road, Andover, Massachusetts 01810

Tour Limit:
First 60 registrants

Tour Times (by advanced reservation only):
3:30 p.m. – 5:00 p.m.

Dinner Meeting Location:
The Holiday Inn Tewksbury / Andover, 4 Highwood Drive, Tewksbury, Massachusetts 01876
(978) 640-9000 www.TewksburyHotelandEvents.com 

Meeting Limit:
200

Dinner Meeting Times:
5:30 p.m. – 9:00 p.m.
Registration/Networking 5:30 p.m. – 6:30 p.m.
Dinner Meeting 6:30 p.m. – 9:00 p.m.

Price via PDA Web by noon (EST) on November 7:
PDA Members: $40
PDA Non-Members: $70
Students / In Transition: $10

Price at door if space is available:
PDA Members: $45
PDA Non-Members: $75
Students / In Transition: $10

Recommended Readings:
Destin A LeBlanc - Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing

Cancellation Policy:
Full refund if cancellation request is sent by FAX to Trevor Swan at 301-986-0296 by noon on November 7, 2008

Sponsorships (additional sponsorships are available):
Representatives from the following companies will be available to explain their products and services and to answer your questions:

• Accugenix, http://www.accugenix.com/

• ARAMARK Cleanroom Services, http://www.aramark-cleanroom.com/

• Baxter Healthcare Corporation, www.baxterbiopharmasolutions.com

• Biotest Diagnostics Corporation, www.biotestusa.com

• Charles River, http://www.criver.com/

• Chisholm Corporation, www.thechisholmcorp.com

• Commissioning Agents, Inc., http://www.commissioningagents.com/

• General Econopak, Inc, www.generaleconopak.com

• Masy Systems, www.masy.com

• Steris Corporation, http://www.steris.com/

Registration Contacts:
Myron Dittmer: mdittmer@mfdassociates.com
Chris Meyer: chris.meyer@lonza.com
Rusty Morrison: morrison@pdachapters.org

Registration Instructions:
Online registration is now closed. We may still have space for the meeting. To register send an email to zaczkiewicz@pdachapters.org along with your name, company, phone number. and PDA membership status. I will then reply to confirm registration. Payment will be by cash or check at the door ($45 members/ $75 non-members).