7th CMO Quality Oversight & Risk Management Summit - Boston, MA

7th CMO Quality Oversight & Risk Management Summit
April 24 - 25, 2017
Boston, MA
Boston, MA

Foster a Culture of Quality with CMOs and CGMP in Accordance with Regulations and Best Safety Practices for Pharmaceutical and Combination Products

Agenda – 7th CMO Quality Oversight & Risk Management Summit



Day One

 Monday, April 24, 2017

9:00AM – 9:15AM

Co-Chairpersons’ Opening Remarks


Lisa Alexander, Vice President, Quality and Regulatory, BRAMMER BIO
Stan Russell, Head of Quality - Due Diligence, Partnerships and Integration, SHIRE

9:15AM – 10:00AM

Use Risk to Manage Oversight of a CMO


Isabel Molina, Principal Technical Manager, External Quality, GENENTECH
Eva Urban, Senior Manager, Global Quality Risk Management, CELGENE

10:00AM – 11:00AM

Carousel Discussion Exercise


11:00AM – 11:15AM

Networking Break


11:15AM – 12:00PM

Select the Best CMO Using Poignant and Honed Criteria in Five Key Areas for Evaluating Risk and Partner Suitability


Robert Beall, Associate Director, Program Management, PROPHARMA GROUP

12:00PM – 1:00PM

Luncheon


1:00PM – 1:45PM

Panel: Effect Technology Transfer for Biologics


Heidi Hoffmann, Senior Director, Supply Chain and CMC Team Lead, SUTRO BIOPHARMA
Amnon Eylath, Head of Quality, KARYOPHARM THERAPEUTICS, INC.

1:45PM – 2:30PM

Case Study: Implement an Integrated Risk Management Program for External Manufacturing


Susan Qu, Integrated Risk Manager, External Manufacturing, SANOFI BIOLOGICS
Brid Rooney, QA Director, Genzyme External Manufacturing, SANOFI BIOLOGICS

2:30PM – 3:15PM

Safeguard Quality by Customizing Your Audit to Accurately Assess Critical Measures


Lisa Alexander, Vice President, Quality and Regulatory, BRAMMER BIO

3:15PM – 3:30PM

Networking Break


3:30PM – 4:15PM

Learn the Implications of the FDA’s Draft Document on Data Integrity and Compliance with cGMP Guidance for Industry


Dale Herbranson, Vice President, Quality and Regulatory - Tech Group, Contract Manufacturing, WEST PHARMACEUTICAL SERVICES

4:15PM – 5:00PM

Master Quality Metrics from Cognizance to Compliance


Adnan Sabir, Director, Manufacturing Quality Guidance and Policy, KOWA PHARMACEUTICALS AMERICA

5:00PM – 5:45PM

Understand Your Process:  A Key to CMO Risk Mitigation


Eric W. Smart, Senior Advisor, Aseptic Manufacturing, SINGOTA SOLUTIONS


Day Two

 Tuesday, April 25, 2017

8:00AM – 9:00AM

Continental Breakfast


9:00AM – 9:15AM

Co-Chairpersons’ Recap of Day One


Lisa Alexander, Vice President, Quality and Regulatory, BRAMMER BIO
Stan Russell, Head of Quality - Due Diligence, Partnerships and Integration, SHIRE

9:15AM – 10:00AM

Clarify Expectations of FDA's Quality Agreements Guidance 


Paula Katz, Director of Manufacturing Quality Guidance and Policy, Office of Compliance, FDA

10:00AM – 10:45AM

Manage Risk While Working with Emerging Markets


Dan Trimberger, Director QA, MOMENTA PHARMACEUTICALS

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

Maintain CMO Quality Oversight Through Mergers and Acquisitions


Stan Russell, Head of Quality - Due Diligence, Partnerships and Integration, SHIRE

12:00PM – 1:00PM

Luncheon


1:00PM – 1:45PM

Institute Best Practices for CMO Oversight in the Emerging Tech Space


Khandan Baradaran, Vice President and Global Head of Quality, DIMENSION THERAPEUTICS

2:30PM – 3:15PM

Establish Multi-Step Quality Control Procedures for Biologics During Technology Transfers to New Markets


Todd Mabe, Head of Biologics, Drug Substance, GENENTECH

3:15PM – 3:30PM

Co-Chairpersons’ Closing Remarks


Lisa Alexander, Vice President, Quality and Regulatory, BRAMMER BIO
Stan Russell, Head of Quality - Due Diligence, Partnerships and Integration, SHIRE


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