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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Modern Biopharmaceutical Processing Conference

From Facility Design to Product Distribution
Nov 28 - Nov 29, 2017 |
Nov 29, 2017 |
Hilton Singapore | Singapore, Singapore
  • Conference
  • Western Hemisphere Events
  • Asia-Pacific
Exhibition: November 28-29
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Singapore has become an established global center of biopharmaceutical manufacturing. The goal of the 2017 PDA Modern Biopharmaceutical Processing Conference is to address all relevant aspects that need to be considered when manufacturing modern biopharmaceuticals.

The Conference will address:

  • The latest development in regulations
  • Technology transfers and upscaling from research to manufacturing site
  • Processing, especially in single use systems
  • Continuous manufacturing approaches
  • Challenges of temperature-controlled distribution of biopharmaceuticals in the global supply chain

Sessions will include a case study of a new Singapore facility for biopharmaceuticals manufacturing, details on experiences with process, regulatory agencies and business-related advantages and a technology update session will show new trends in technologies for the pharmaceutical industry. There will be plenty of time for discussion and questions during the panel discussions as well as networking opportunities with your peers. There will also be an exhibition presenting equipment and services.

Who Should Attend

Manager; Leader; Supervisor; Branch Chief | Director | Scientist; Researcher | Engineer

Speciality Area/Areas of Interest

Biotech | Process Validation | Quality | Technology Transfer | Data Integrity | Regulatory Affairs | Facilities and Engineering | Manufacturing | Research

Tuesday, 28-November

7:30 a.m. – 5:30 p.m.
Registration Open

7:30 a.m. – 8:30 a.m.
Continental Breakfast

8:30 a.m. – 8:45 a.m.
Welcome and Opening Remarks from PDA Leadership
Richard M. Johnson, President and CEO, PDA

8:45 a.m. – 10:45 a.m.
P1: Opening Plenary: Regulatory Updates
Moderator: Richard M. Johnson, President and CEO, PDA

Session Description: The pharmaceutical industry is a regulated industry, therefore assessors and inspectors of health authorities are important partners of the industry. This session will highlight the latest regulations and regulators will share their observations from inspections.

8:45 a.m. – 9:15 a.m.
PIC/S Update
Boon Meow Hoe, Deputy Director (Overseas Audit)/Senior GMP Auditor, Health Sciences Authority (Singapore) (Invited)

9:15 a.m. – 9:45 a.m.
Health Authority Perspective: U.S. FDA
Alicia M. Mozzachio, MS, Senior Advisor for International Activities, CDER, FDA 

9:45 a.m. – 10:15 a.m.
Industry Perspective on API Regulations
Stephan Rönninger, PhD, Dr.-Ing. Director International Quality External Affairs, Amgen Inc.

10:15 a.m. – 10:45 a.m.
Questions and Answers/Discussion

10:30 a.m. – 7:00 p.m. 
Exhibit Area Open

10:45 a.m. – 11:15 a.m.
Refreshment Break in Exhibit Area

11:15 a.m. – 12:30 p.m.
P2: Facility Design, Single-Use Systems, and Cleaning Requirements
Moderator: Wayne Lee, PhD, MBA, Director, Biopharmaceuticals, Asia-Pac, Pall Corporation

Session Description: This session discusses the different facility concepts for single use processes. Based on PDA Technical Report No. 66, the relevant aspects from project initiation to execution will be addressed. In addition, maintenance, cleaning, and disinfection for modern single-use-system environments will be highlighted.

11:15 a.m. – 11:45 a.m.
Facility Concepts on Single-Use Systems: PDA Update on Technical Report No. 66
Morten Munk, Global Technology Partner, NNE

11:45 a.m. – 12:15 p.m.
Facilities: Cleaning and Disinfection: How Much is Needed?
Jim Polarine Jr., MA, Senior Technical Service Manager, STERIS Corporation

12:15 p.m. – 12:30 p.m.
Questions and Answers/Discussion

12:30 p.m. – 1:30 p.m.
Networking Luncheon

1:30 p.m. – 3:15 p.m.
P3: Single-Use Systems
Moderator: Anthony Morandi, Head of Operations Quality Global Strategy and Transformation, AstraZeneca

Session Description: Single-use systems play a significant role in the manufacturing of biopharmaceuticals. This session addresses challenges when working with single-use systems, especially handling, extractables and leachables, particles, and leak testing. The latest requirements from regulations will be considered as well.

1:30 p.m. – 2:00 p.m.
Single-use Particulates Risk Management
Patrick Evrard, Senior Director SLS, Single Use Technologies, Pall Corporation

2:00 p.m. – 2:30 p.m.
Extractables and Leachables
Piet Christiaens, PhD, Scientific Director, Toxikon Europe

2:30 p.m. – 3:00 p.m.
Case Study: Development of a Helium-based Supplier Integrity Testing Method for SUS Integrated into a Global Container Closure Integrity Strategy
Carole Langlois, MBA, Senior Product Manager, Sartorius Stedim Biotech

3:00 p.m. – 3:15 p.m.
Questions and Answers/Discussion

3:15 p.m. – 3:45 p.m.
Refreshment Break in Exhibit Area

3:45 p.m. – 5:45 p.m.
P4: Continuous Processing
Moderator: Arleen Paulino, Vice President, Singapore Site Operations, Amgen Inc.

Session Description: Continuous processing is the hot topic in pharmaceutical manufacturing. This session will give an overview of current best practice for continuous processing of biopharmaceutical products. Focus will be on the use of single-use systems and the unit operations: cell culture perfusion, chromatography, viral clearance, and filtration processes will be considered in a continuous processing approach.

3:45 p.m. – 4:15 p.m.
Continuous  Bioprocessing Using Single Use Systems
Parrish M. Galliher, MS, Chief Technology Officer, Upstream, GE Healthcare Life Sciences

4:15 p.m. – 4:45 p.m
Continuous Processing Optimization with Smarter Tools
Barbara Paldus, PhD, Vice President/General Manager, Finesse, a part of Thermo Fisher Scientific

4:45 p.m. – 5:15 p.m.
Continuous Processing of Biopharmaceuticals: Virus Clearance
Laura Holtmann, MS, Research Associate, Bayer/INVITE GmbH

5:15 p.m. – 5:45 p.m.
Use of Process Analytics in Continuous Primary Manufacturing
Martin W. Hermanto, PhD, Chemometrician, GlaxoSmithKline
Clarence Wong, Technical Development Manager, GlaxoSmithKline 

5:45 p.m. – 6:00 p.m.
Questions and Answers/Discussion

6:00 p.m. – 7:00 p.m.
Networking Reception in Exhibit Area

Wednesday, 29-November

8:00 a.m. – 2:15 p.m.
Registration Open

8:00 a.m. – 9:00 a.m.
Continental Breakfast

8:00a.m. – 8:45 a.m.
Breakfast Session: Biotechnology Update
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development, PDA

Session Description: This session gives suppliers of machines and processing and testing equipment as well as service providers an opportunity to share their latest technologies and services.

7:30 a.m. – 7:45 a.m.
Merck

7:45 a.m. – 8:00 a.m.
Asahi

8:00 a.m. – 8:15 a.m.
DHL
Leonora Lim, Vice President, Life Sciences and Healthcare, Asia Pacific, DHL

8:15 a.m. – 8:30 a.m.
Bosch Pharmatec
Ralf Kretzschmar, General Manager, Bosch Pharmatec

8:30 a.m. – 8:45 a.m.
From Theory to Practice: Scale Up and Transfer
Chervee Ho, Director of Key Account Management, Asia Pacific, Vetter Pharma-Fertigung


9:00 a.m. – 10:45 a.m.
P5: Advancing Manufacturing Operations: Amgen Case Study
Moderator: Andiyanto Sutandar, Technical Director, HGP Asia Pte. Ltd.

Session Description: The session will be introduced with a presentation on risk-based approaches for continuous manufacturing. Amgen has built a facility that recently went into operation.This presentation will cover differences, advantages, and challenges between traditional and single-use manufacturing plants. A panel discussion will follow addressing facility, continuous processing, closed systems, and regulatory aspects of such systems and a representative from Amgen will share their experiences.

9:00 a.m. – 9:30 a.m.
Risk-based Approach for Continuous Manufacturing
Wayne Lee, PhD, MBA, Director, Biopharmaceuticals, Asia-Pac, Pall Corporation

9:30 a.m. – 10:15 a.m.
Case Study: Modern Biopharmaceutical Facility
Arleen Paulino, Vice President, Singapore Site Operations, Amgen Inc.

10:15 a.m. – 10:45 a.m.
Panel Discussion: Facility, Closed Systems, Continuous Processing, and Regulatory Requests

10:15 a.m. – 4:00 p.m.
Exhibit Area Open

10:45 a.m. – 11:15 a.m.
Refreshment Break in Exhibit Area

11:15 a.m. – 12:45 p.m.
P6: Technology Transfer
Moderator: Sudhir Goudar, Executive Director-Senior Compliance Officer, Group Compliance and Audit, Novartis

Session Description: Technology transfers from development to the manufacturing site is very important. Because of the complexity, early planning with a competent project team is most crucial to avoid delays in product launch. In this session, the most relevant points are summarized and highlighted in two case studies covering the technologies, processes, regulations, people, and their culture.

11:15 a.m. – 11:45 am
Technology Transfer with Process Change
Gary Khoo, PhD, Head of Manufacturing, Shire

11:45 p.m. – 12:15 p.m.
Industry Case Study: New Product Launch in Singapore
Immaculada Gomez, Tech Transfer Lead, MS&T, Novartis NTO Solids, Singapore
Maud Grachet,
Product Steward, MS&T, Novartis NTO Solids, Singapore

12:15 p.m. – 12:45 p.m.

Questions and Answers/Discussion

12:45 p.m. – 2:00 p.m.
Networking Luncheon

2:00 p.m. – 4:00 p.m.
P7: Good Distribution Practice: Temperature-Controlled Distribution of Biopharmaceuticals
Moderator: David Spaulding, Partner and Training Manager, SeerPharma

Session Description: In the global environment, APIs and pharmaceutical products can have an extended supply chain. APIs are transported to the fill-finish site, filled containers are brought to the labelling and packaging site, and, later to the wholesaler, clinic, or patient. Mechanical stress and temperature excursion might have an impact on product quality; therefore it has to be ensured that through the whole supply chain the transported goods are in a state of control. This session will address such issues from the practical point of view.

2:00 p.m. – 2:30 p.m.
Controlled Freeze and Thaw Process for Monoclonal Antibody Solutions 
Michael J. Marciniak, MS,
Senior Product Manager, Freeze-Thaw Technologies, Sartorius 

2:30 p.m. – 3:00 p.m.

Temperature Control and Monitoring of Pharmaceuticals in the Supply Chain
Elizabeth Darragh, Vice President, Global Marketing Communications, Sensitech Inc.

3:00 p.m. – 3:30 p.m.
Distribution of Biopharmaceuticals: Challenges of Transportation of Temperature Controlled Products
Leonora Lim, Vice President, Life Sciences and Healthcare, Asia Pacific, DHL

3:30 p.m. – 4:00 p.m.
Questions and Answers/Discussion

4:00 p.m.
Closing Remarks from Conference Chair
Georg Roessling, PhD, Senior Consultant, Business Development, PDA

Conference Registration | November 28-29, 2017

Member

$895

Non-member

$1,195


Government/Health Authority/Academic

Member

$400

Non-member*

$400


Student

Member

$150

Non-member*

$150


All prices in US dollars.

* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund and photo release policies for this Conference.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may accommodate. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by September 29, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). If your written request in received on or before September 29, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for this event, 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.

Hilton Singapore
581 Orchard Road
Singapore, 238883, Singapore
Phone: +65-67-372-233

Rate: S$280.00++ per room per night (Single) or S$300.00++ per room per night (Double)
*The bedroom rates are inclusive of buffet breakfast and internet for one/two and are exclusive of 10% service charge and 7% goods & services tax

Situated in the heart of Orchard Road, a popular entertainment and shopping district, Hilton Singapore is close to both ION Orchard and Takashimaya shopping centers. This hotel is only 20 minutes from Singapore Changi International Airport and close to Singapore’s popular attractions.

Information Coming Soon.
Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3820

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