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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Southern California Chapter Quarterly Event - Biologics

Jun 15 - Jun 15, 2017 |
Jun 15, 2017 |
Allergan | Irvine, CA
  • Chapter
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The evening will feature two presentations on biologics:

Product and Process Design for Biologics
by Mihaela Simianu, PhD, Director Regulatory Compliance, Pharmatech Associates

All Things Considered: CMC and QMS Intersection in Process Development
by Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates


mihaelasimianuDr. Simianu is an experienced executive leader in Bio-Pharmaceutical industry. She has diverse and deep expertise in development, commercialization and international manufacturing of complex bio-pharmaceuticals used in the treatment of multiple forms of cancer and diseases associated with endocrine, cardiovascular, neurological, and immunological disorders. She has successfully built new and flexible technical organizations, implemented improvements to development, quality and manufacturing systems, and has established technical and social capabilities that contributed to the success of multi-billion dollar organizations. In her role as Director of Regulatory Compliance at Pharmatech Associates she guides companies to apply a tailored "Compliance trough Science "approach to commercialization of complex therapeutic agents, balancing regulatory, compliance, and technical requirements with business needs. As a recognized international industry expert, Dr. Simianu has engaged in organizing numerous global events for the Parenteral Drug Association. She has spoken on many occasions on the application of science to quality and manufacturing practices.


bikashchatterjeeMr. Chatterjee has more than 30 years of experience in the pharmaceutical, biosciences, medical device/diagnostic and nutraceutical/dietary supplement industries. He has held senior management positions in operating companies for more than a decade and has successfully brought multiple drug and product platforms through the FDA regulated development process to market. He has successfully designed and implemented Quality, Engineering and Operations Management Systems for organizations in the US, Europe and Asia. Mr. Chatterjee holds multiple certifications including Lean Six Sigma Master Black Belt and is a Certified Lead Assessor. He has published over 80 articles and editorials throughout his career in peer reviewed journals. Mr. Chatterjee holds a BA in Biochemistry and a BS in Chemical Engineering from the University of California at San Diego.

Networking and Light Meal: 4:00-5:00PM

Presentations/Q&A: 5:00-7:00PM

Networking and Dessert: 7:00-7:30PM

General Registration

PDA Member

On or Before June 08, 2017
$50

After June 08, 2017
$60

Non-member

On or Before June 08, 2017
$65

After June 08, 2017
$75

 

Government/Student Member

On or Before June 08, 2017
$25

After June 08, 2017
$35

Trouble Registering Online? Download the manual registration form.


Employees of Event Host Facilities

Organogenisis Employees

On or Before June 08, 2017
No Charge

After June 08, 2017
$10

Allergan Employees

On or Before June 08, 2017
No Charge

After June 08, 2017
$10

Trouble Registering Online? Download the manual registration form.


CANCELLATIONS: Receive a full refund until June 1, 2017 / 50% refund through June 8, 2017 / no refund after June 8, 2017.

SUBSTITUTIONS: Please no substitutions.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Recordings are prohibited at all PDA Conferences.

Allergan Facility
2525 Dupont Drive
Irvine, CA 92612
allerganmap


Organogenesis Facility
10933 N. Torrey Pines Road
La Jolla, CA 92037

From the North

Take Exit 29 onto Genesee Ave
Turn Right onto Genesee Ave
Bear Right onto N. Torrey Pines Road
The destination is on your right

From the South

Take Exit 29 onto Genesee Ave
Turn Left on Genesee Ave
Bear Right onto N. Torrey Pines Road
The destination is on your right
organogenesismap

Sponsorships Available

We are grateful to our dedicated members and sponsors for their continued interest, participation and support. Without our sponsors, we would not be able to provide the educational and social networking to the membership. Please consider participating in our 2017 June Biologics Event.

What's Included

There are four sponsorship opportunities available at each location and benefits are provided below:

6' foot table, logo & company description on all marketing material w/ hyperlink, 60 second announcement, two admission tickets

This event provides an excellent opportunity for you to be in front of potential end users to present your products and services and get high visibility to the SoCal Life Science Industry.

Sign Up Now

If you’re interested in sponsoring in our Q2 program please download and complete the registration form and fax it to PDA, Trevor Swan/Katie Ruiz at 301-986-0296, or email to ruiz@pda.org.  Incomplete forms will not be processed.

For more sponsorship information please contact Randy George at 949-632-1802 or Ileana Ayala at 787-903-0740.

Register Now
https://www.pda.org/chapters/north-america/southern-california/event-detail/pda-southern-california-chapter-event-registration

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