[IEEE-bhpjobs] [Fwd: PDA Southeast Chapter - Mar 17 Spring Conference Speaker UPDATE]
Esther L
esther_L at ieee.org
Thu Feb 26 21:56:10 EST 2009
-------- Original Message --------
Subject: PDA Southeast Chapter - Spring Conference Speaker UPDATE
Date: Thu, 26 Feb 2009 17:58:13 -0500 (EST)
From: Debora Steenson <pdase at bluestarservices.net>
Reply-To: pdase at bluestarservices.net
To: esther_l at ieee.org
*/Regulatory & Compliance /*
*PDA Southeast Chapter*
*2009 Annual Spring Conference*
*Tuesday, March 17, 2009*
*GlaxoSmithKline*
*Research Triangle Park, NC*
*Current Regulatory and Compliance Topics*
* *
Registration includes all educational sessions, breaks and lunch.
Attendee $85 Student Registration $30
Pre-registration is required due to the location of the meeting.
For individual online registration, either utilize form below or go to
http://pdachapters.org/southeast/component/option,com_jcalpro/Itemid,37/extmode,view/extid,25/
<http://rs6.net/tn.jsp?et=1102478383335&e=001rZUaq_h9QpusmOOZ8DytzXg7Ngh3pRG7efd9Xh7hWZilI2AoYiEJ793PCRJ5N0oD1wn4aOqe-sGgxbjBlwdrnAVQecsejghETWHnFpfhL_DX_kjsaD5BB_cOG1KHZ59pUIhSZZG6NeTJNbZDxvYTYXHya5_bnDFVytjznNHuX-OBtSLj3XCP6Cp8VYoyqttiuiGrq2RZpmBJ7QaDb8ZYDCdWxpF3D3bgSBf7woZPu4Q=>
A special discount of $5.00 per person is offered,
when three (3) or more company members register at the same time.
The form below must be used and faxed or e-mailed as outlined below.
PDA Southeast Chapter has maintained registration rates since 2006 in an
effort
to support our loyal attendees.
If your company is interested in sponsoring, please contact Debora
Steenson at pdase at bluestarservices.net or by calling 919.418.1325.
Agenda
9:00 am
9:30 am
Registration
9:30 am
10:00 am
Welcome/Chapter Meeting
10:00 am
11:00 am
*Regulatory and Business Strategies to Support New Drug-Device
Combination Projects*
/Stephen M. Perry, PMP - Kymanox/
There is an increasing trend in the number of new products in
development that fall under the classification of a "drug-device
combination" or "biologic-device combination." Inter-center agreements
between CDER, CBER and CDRH exist and define the jurisdiction of these
combination products. The overall filing strategy and required
competencies to accomplish a successful combination approval are usually
not pre-defined at pharmaceutical and biotechnology companies unless
there has been a strong history of such programs. Although there are
some shared regulatory, compliance and quality aspects between drugs and
devices, there are also some key differences that require special
attention and planning. It is imperative that a comprehensive plan is
put in place early in the development process to ensure efficient and
proactive navigation amongst the FDA's governing regulatory bodies.
/Stephen M. Perry, PMP is the founder and president of Kymanox - a
diversified company specializing in technical project management for the
pharmaceutical, biotechnology and medical device industries. He has a
well over decade of cGMP manufacturing experience as a process engineer,
technical project manager and quality advisor. Stephen has led three
multi-million dollar capital projects and has contributed to five major
facility installations which began at the conceptual design phase.
Before starting Kymanox, Stephen had various leadership roles supporting
scale-up, start-up and commercialization initiatives at Abbott
Laboratories, Covance Biotechnology Services, Diosynth Biotechnology and
Human Genome Sciences./
/During his career, Stephen participated with increasing
responsibilities in the FDA commercial approval of products such as
Cyclosporine (Gengraf®), Aminoethoxy-Vinyl-Glycine (ReTain®) and
Pegvisomant (SOMAVERT®). Stephen was the operations technical lead for
the commercial transfer of Reteplase (Retavase®) from Germany to the
USA. Stephen's Phase III technology transfer work with HspE7, a novel
cancer drug, and Everninomycin, a super-potent antibiotic, are notable
from a technology transfer perspective./
/Stephen has a liberal education background with a high-honors
bachelor's degree in Chemical Engineering from the University of Notre
Dame and studied at the graduate level at Purdue University. Stephen is
member of the International Society of Pharmaceutical Engineering (ISPE)
and is a certified Project Management Professional (PMP) by the Project
Management Institute./
11:00 am
12:00
*Global Inspection Trends*
/Debra L. Pagano /
Global inspection trends are critical to understand at the present time.
With the movement of materials, components, and products on a worldwide
basis it is critical to have an broad understanding of inspection
techniques and expectations.
Regulatory actions stem from FDA-483 observations. These actions can
delay product approvals as well as damage a company's reputation.
Knowing applicable regulations (such as the FDA, EMEA, MHRA, etc.) and
guidelines are beneficial but may not be enough to adequately address
expectations. Come and hear what FDA investigators are looking for based
on top FDA-483 and global observations.
What are global regulatory inspection expectations?
Are regulations and guidance documents enough?
How can the lack of focus on expectations adversely impact an
organization's operations?
What are the current, common FDA-483, EMEA, and MHRA observational trends?
How do present and past observations compare?
What can we expect based on past and present?
/ /
/Debra L. Pagano is a Senior Compliance Consultant for IHL Consulting
Group, Inc. Ms. Pagano worked for the Food and Drug Administration for
17 years. In that role, she was the Pre-Approval Program Manager from
October 1994 to October 2002 and previously held positions as drug
specialist and investigator. Ms. Pagano has provided the Pharmaceutical
Industry as well as FDA investigators and chemists, training in various
drug program areas. Ms. Pagano was a course advisory member and teacher
for FDA's Pre-Approval Inspection Training Course for Investigators and
Chemists; FDA's Pre-Approval Manager Update session and FDA's Basic Drug
School./
/Ms. Pagano is an adjunct professor for Temple University's Quality
Assurance/Regulatory Affairs Masters Program. She has conducted numerous
inspections in the pre-approval program and pharmaceutical areas and was
on FDA's Foreign International cadre./
12:00
1:30 pm
Networking Lunch/Visit with Vendors
1:30 pm
2:30 pm
*The Concept of Variability in the 21st Century Regulatory Environment*
/Brian K. Nunnally, Ph.D./
/ /
The pharmaceutical environment of the 21st century will be focused on
the understanding and control of variability. Regulatory agencies, the
FDA in particular, are moving in the same direction as well. The recent
draft Process Validation guidance issued by the FDA is a perfect example
of this trend. In this presentation, the linkage between the reduction
of variability and the improvement in business and quality attributes
will be discussed. This sets the stage for improved production and
increased compliance.
/Brian K. Nunnally, Ph.D. is currently the Associate Director of Process
Validation at Wyeth. Dr. Nunnally has authored numerous publications in
the fields of analytical chemistry and Six Sigma and has given lectures
in a variety of analytical chemistry subjects. He is an assistant
editor of several industry journals. Dr. Nunnally also is a member of
two United States Pharmacopeia (USP) 2005-2010 Expert Committees,
Reference Standards and Biotechnology and Biologics: Vaccine and Virology. /
/He has two B.S. degrees from the University of South Carolina, and a
Ph.D. in chemistry from Duke University. /
/ /
/Recently he worked in TO&PS Regulatory Affairs where he was responsible
for leading the Wyeth Sanford site's contributions to one of the biggest
filings in pharmaceutical history. Prior to that he was the Associate
Director for GMP Operations in Vaccine Analytical Development at Wyeth.
He had additional experience at Eli Lilly and Co., where he was
responsible for leading a Quality Control laboratory devoted to new
method development, method optimization, analytical testing for process
validation, and analytical testing for manufacturing investigations./
2:30 pm
3:00 pm
Break with Vendors
3:00 pm
4:00 pm
*PANEL DISCUSSION on Current Regulatory/Compliance Topics*
Submitted and audience questions
Stephen M. Perry - President of Kymanox
Debra L. Pagano - President of FDA Consultants, LLC
Brian K. Nunnally - Associate Director of Process Validation -Wyeth
DIRECTIONS TO GSK
Girolami/R&D Administration Building
(Building 5)
From I-40 East &/or West, exit onto the Durham Freeway North (147 North).
Take the Durham Freeway North (147 North) to Alexander Drive (second
exit on Freeway).
Go left onto Alexander Drive.
Go to the second stoplight and go right into the main entrance of Glaxo
SmithKline (Moore Drive).
Stop at the guard station and say that you are attending the PDA meeting.
Continue on Moore Drive until it curves to the left. The Girolami/R & D
Administration building (Building 5) is on the right.
Turn right into the driveway and immediately on your right, there will
be a visitor parking lot. If the lot is full, park on Moore Dr. in
front of the building. Come into the lobby of the Girolami Bldg. There
will be a registration table where you will sign in.
*/PDA Southeast Chapter 2009 Spring Conference Registration/*
*Attendee #1 (Please print)*
First Name ________________________________________________________________
Last Name ________________________________________________________________
Company ________________________________________________________________
Address _________________________________________________________________
City/State/Zip
____________________________________________________________
Telephone ________________________________________________________________
Fax _____________________________________________________________________
E-mail __________________________________________________________________
*Attendee #2 (Please print)*
First Name ________________________________________________________________
Last Name ________________________________________________________________
Company ________________________________________________________________
Address _________________________________________________________________
City/State/Zip
____________________________________________________________
Telephone ________________________________________________________________
Fax _____________________________________________________________________
E-mail __________________________________________________________________
*Attendee #3 (Please print)*
First Name ________________________________________________________________
Last Name ________________________________________________________________
Company ________________________________________________________________
Address _________________________________________________________________
City/State/Zip
____________________________________________________________
Telephone ________________________________________________________________
Fax _____________________________________________________________________
E-mail __________________________________________________________________
*PAYMENT INFO*
Attendee $85 or Student $30 per person
Total Payment$_____________ (3 or more deduct $5.00/person-must register
at the same time)
Payment Method _______Check (Preferred Method)
____VISA ____ M/C ____ AE ____ Diners Club
Name as it appears on card
___________________________________________________________
Address where card statement is sent
___________________________________________________
Card Number ___________________________________
Exp. Date ________ Security Code _______
Authorized Signature
________________________________________________________________
*Complete and fax this form with payment info to:*
PDA Southeast Chapter FAX #919.278.2647
Or mail this form with payment to:
PDA Southeast Chapter
c/o Blue Star Services
1829 East Franklin St. - Suite 600
Chapel Hill, NC 27514
Questions? Call Debora Steenson, Chapter Manager at 919.418.1325
Forward email
<http://ui.constantcontact.com/sa/fwtf.jsp?m=1102050881502&ea=esther_l%40ieee.org&a=1102478383335>
Safe Unsubscribe
<http://visitor.constantcontact.com/d.jsp?v=001Cz2gV83Vs3qYCCyCkqS--FviPDq-DyHKBTXR1G6dATlTTGslfYMslmta_mE1sJkp&p=un>
This email was sent to esther_l at ieee.org by pdase at bluestarservices.net
<mailto:pdase at bluestarservices.net>.
Update Profile/Email Address
<http://visitor.constantcontact.com/d.jsp?v=001Cz2gV83Vs3qYCCyCkqS--FviPDq-DyHKBTXR1G6dATlTTGslfYMslmta_mE1sJkp&p=oo>
| Instant removal with SafeUnsubscribe
<http://visitor.constantcontact.com/d.jsp?v=001Cz2gV83Vs3qYCCyCkqS--FviPDq-DyHKBTXR1G6dATlTTGslfYMslmta_mE1sJkp&p=un>™
| Privacy Policy <http://ui.constantcontact.com/roving/CCPrivacyPolicy.jsp>.
Email Marketing
<http://www.constantcontact.com/index.jsp?cc=TEM_BusLet_003> by
<http://www.constantcontact.com/index.jsp?cc=TEM_BusLet_003>
PDA Southeast Chapter | c/o Blue Star Services | 1829 East Franklin St.
- Ste 600 | Chapel Hill | NC | 27514
--
-- Esther L., esther_L (at) ieee.org, Speaking only for myself.
If your email to me bounces, check the _L and the H in esther.
-------------- next part --------------
An embedded and charset-unspecified text was scrubbed...
Name: file:///C|/DOCUME%7E1/ESTHER/LOCALS%7E1/TEMP/nsmail.txt
URL: <http://rtpnet.org/pipermail/ieee-bhpjobs/attachments/20090226/bf61b04d/attachment.txt>
More information about the IEEE-bhpjobs
mailing list