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


Amnon Eylath, Head of Quality, KARYOPHARM THERAPEUTICS, INC
Heidi Hoffmann, Senior Director, Supply Chain and CMC Team Lead, SUTRO BIOPHARMA
Todd Mabe, Director, Drug Substance Quality, Quality Lifecycle Management, MERCK

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, CDER, FDA

10:00AM – 10:45AM

Manage Risk While Working with Emerging Markets


Dan Trimberger, Senior 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, Director, Drug Substance Quality, Quality Lifecycle Management, MERCK

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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