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Balancing the Challenges and Expectations of QbD Like Thinking in the Age of Pharmaceutical Outsourcing

The Southern California Pharmaceutical Discussion Group (SCPDG) of AAPS

Thursday, October 19, 2017 from 6:00 PM to 8:30 PM (PDT)

Balancing the Challenges and Expectations of QbD Like T...

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Ticket Type Sales End Price Fee Quantity
Working Professional/ Consultant - AAPS member 14h 31m $35.00 $2.92
Working Professional/ Consultant - Non AAPS member 14h 31m $40.00 $3.19
Full Time Student/ Retired/Unemployed 14h 31m $15.00 $1.82

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Event Details

The Southern California Pharmaceutical Discussion Group (SCPDG) of AAPS announces:

Balancing the Challenges and Expectations of

QbD Like Thinking

in the Age of Pharmaceutical Outsourcing

Presented by

Bhavishya Mittal, Ph.D.

Associate Director, Implants and Oral Product Development (IOPD)

Allergan Pharmaceuticals, Irvine, CA

When:  Thursday, October 19, 2017 at 6:00 PM

Where: Waters Corporation Regional Office, 18271 McDurmott E, Suite D, Irvine, CA 92614

Agenda: 6:00-6:30 PM Check-In and Networking, 6:30-7:15 PM Dinner, 7:15-8:30 PM Presentation and Discussion

Registration: Please register by Friday, October 13, 2017 using link below:

http://scpdgoct2017.eventbrite.com

Attendance is by pre-registration only – no walk-ins please.
Registration fee includes dinner and presentation.

Working Professional (includes consultants) - $40

Working Professional/AAPS member-$35

Student (full-time)/ Retired/ Unemployed (no consultants) - $15

Abstract:

Outsourcing has emerged as a successful business model for numerous pharmaceutical companies. Due to increased competitive and market pressures to contain fixed costs, all pharmaceutical companies are looking for ways to strategically increase their outsourcing capabilities and to augment their inhouse resources. To a large extent, these sponsor companies rely on outsourcing service providers more than ever to fulfill their tasks, solve their problems, improve their efficiency, and productivity. Therefore, it is not surprising that a significant amount of resources is expended toward project management and effective communication. However, it is very important for scientific personnel involved in tech transfer, and scaleup to understand the variations in material properties of drug substance and excipients, manufacturing design space, equipment, container closure studies, and SUPAC implications earlier in the product’s development cycle. This presentation will focus on strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science.

 

Biography:

Bhavishya Mittal is an Associate Director in the Implants and Oral Product Development (IOPD) Department at Allergan Pharmaceuticals in Irvine, CA. Prior to Allergan, Bhavi worked at the US Food and Drug Administration (FDA) in Silver Spring, MD. Bhavi has a Ph.D. in Materials Engineering from the Pennsylvania State University and a BS in Chemical Engineering from Regional Engineering College, Jalandhar (India).  Bhavi has 14 years of industrial experience in formulation and process development of various solid oral dosages of small therapeutic molecules (oncology, inflammation, and CNS indications) aimed for NDA and ANDA filings.  He is the Vice Chair for the Manufacturing Sciences and Engineering (MSE) section of AAPS.  He is the author/co-author of 1 book, 1 patent, 11 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences.  His research interests include formulation design, process engineering, scale-up and tech-transfer, and computational modeling of pharmaceutical unit operations for solid oral dosage manufacturing.

 

Past Presentations are posted at the below link:

http://www.aaps.org/Southern_California_Pharmaceutical/

Link to Google Maps for Waters Regional Office:

https://www.google.com/maps/place/18271+E+McDurmott,+Irvine,+CA+92614/@33.6887893,-117.8686061,17z/data=!3m1!4b1!4m5!3m4!1s0x80dcdec2b2c90351:0xa8210ac2d069193b!8m2!3d33.6887893!4d-117.8664174

Social Media Links:

http://www.linkedin.com/groups/AAPS-Southern-California-Pharmaceutical-discussion-6601347?trk=my_groups-b-grp-v

 

Have questions about Balancing the Challenges and Expectations of QbD Like Thinking in the Age of Pharmaceutical Outsourcing? Contact The Southern California Pharmaceutical Discussion Group (SCPDG) of AAPS

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When & Where


Waters Corporation Regional Office
18271 McDurmott E, Suite D
Irvine, CA 92614

Thursday, October 19, 2017 from 6:00 PM to 8:30 PM (PDT)


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Organizer

The Southern California Pharmaceutical Discussion Group (SCPDG) of AAPS


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Balancing the Challenges and Expectations of QbD Like Thinking in the Age of Pharmaceutical Outsourcing
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