Education Details

Plenary Sessions ♦ Breakout Sessions ♦ Special Events ♦ Drug Shortage Panel

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Plenary Speakers 

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Information-Packed Topics You Can’t Afford to Miss!

Breakout Sessions 

Quality Metrics

• Begin to define metrics that “define” product quality.
• Discuss other discrete set of metrics that will provide the most value.
• What are “leading indicators."
• Learn best practices that are used internally by companies.
• What will be useful to regulators in making inspection frequency decisions?

Moderators: 
Cindy Salamon, Vice President, Global Quality Services, Bristol-Myers Squibb
Russ Westyk, FDA, Invited

Leadership in Pharma Quality Management

• Learn how great companies build and sustain a culture of quality throughout the product lifecycle.
• Understand leadership behaviors that foster employee commitment to quality.
• Discover how leading companies promote quality as an imperative, not simply a goal.

Moderator: 
Edwin Rivera-Martinez, U.S. Quality Liaison, Global Quality, Sanofi-Aventis

Speakers:

• Monica Caphart, Invited, Supervisory Consumer Safety Officer, Division of Manuf. & Product QualityOffice of Compliance, CDER, FDA, USA
• Victor Gaines, Chemist, CDER/FDA,
• Eric Thostesen, Senior Director, Strategic Business Support, Regulatroy Compliance, Janssen Pharmaceutical Company Inc. of J&J, USA

Process Performance and Product Quality Monitoring System

• Establishing a PPPQMS with concepts of process design, tech transfer and monitoring
• Use of statistics, Control charts and process capability
• Use of statistical modeling in design and development and maintenance over the lifecycle
• Use of metrics to understand halt of the product and overall state of control
• Understand the concept of the Product Quality Steward Model

NEW! ISPE PQLI Guide Series - Part 4: Process Performance and Product Quality Monitoring System Guide will be available at the conference.

Moderator: 
George Millili, PhD., Director, Pharmaceutical Commercialization Technology, Merck & Co, Inc.

Speakers:

• Joseph Famulare, Vice President, Genentech Inc, USA
• Jaspreet Gill, VP, Global Quality and Compliance, Baxter Healthcare Corp, USA
  Establishing and maintaining a State of Control
• Karthik Iyer, Senior Policy Analyst, FDA, USA
  Regulatory Overview PPPQMS
• Claudia Lin, PhD, Berkeley Site Head, Quality Assurance, Development, Bayer Healthcare, USA
  Role of the Quality Steward Keepig a Pulse on the Overall Health of the Product
• George Millili, Ph.D., Director, Pharmaceutical Commercialization Technology, Merck & Co Inc, USA
• Jason Orloff, Principal Statistician, PharmStat, USA
  Variability, Process Capability and Control - How Do You Determine the Right Metrics?

Quality Management of CMOs

• Quality perspective on current challenges with CMO activities.
• How to define your “Critical to Quality” parameters.
• Use of metrics to monitor the “Critical to Quality” parameters.

Moderators: 
Mike Arnold, Senior Director, Strategic Partnerships, Pfizer, Inc.
Mike Smedley, Acting Director, OMPQ, FDA

Speakers:

• Carol Bye, VP, Pharmaceutical Sciences, Quality Operations, Pfizer Worldwide Research and Development, United Kingdom
  Application of Risk Management in the Oversight of Contract Manufacturers for Supply of Product to Clinical Trials
• Zena Kaufman, Sr. VP Global Quality, Hospira, USA
  Contract Manufacturing - A Lifecycle Approach from the perspective of the Contract Manufacturer

Basic PAI Readiness Success and Advent of Breakthrough Therapies

• Discuss readiness for commercial manufacturing.
• Understand appropriate stage validation.
• Hear about the role of data integrity.

Moderator: 
Joe Famulare, Vice President, Genentech, Inc.

Speakers:

• Joanne Barrick, Advisor, Global Validation Support, Eli Lilly & Co, USA
  Process Validation PQLI Efforts to Provide Practical Implementation Methodology - focus on Stage 2 to 3 Leading from Aproval to Commercialization
• David Doleski, Director, Division of Good Manufacturing Practice Assessment (DGMPA), CDER / FDA Office of Compliance, USA
  Challenges to Inspection Readiness
• Earl Dye, Director, Genentech Inc, USA
  Breakthrough Therapy and Challenges for Ensuring Commercial Readiness

CAPA and Lifecycle QRM

• Understand QRM and CAPA differences and how they interact with the product/system lifecycle.
• Build and maintain a robust quality system with feedback loops and Human Error Reduction (HER).
• Gain insight into how CAPA drives quality system improvements.

Moderator: 
Steve Tyler, Director Quality Assurance, AbbVie

Speakers:

• Susan Busse, Director Global Quality Systems, Eli Lilly & Co, USA
  CAPA - Shifting Gears from Correcting to Preventing Problems
• Richard Friedman, Associate Director, OMPQ, FDA/CDER, USA
  Risk Review and Management Responsibilities of CAPA
• Chris Milano, PhD, Senior Director, Quality Operations, Merck, Inc.,
  Quality Risk Management - CAPA System

Continually Investing in Your Facilities and Equipment

• Identify key metrics and indicators for developing facility investment strategies.
• Incorporate risk-based, periodic monitoring into long-term investment plan.
• Employ financial analysis of continual re-investment to avoid mandated capital investments.

Moderator: 
Tim Howard, Vice President, Operations, Commissioning Agents, Inc.

Speakers:

• Steven Driver, PhD, Global Energy Program Director, Genzyme/Sanofi, USA
  Sustainably Commissioning Central Chilled Water Systems
• Steven Lynn, Senior Advisor To the Assistant Commissioner for Operations, Office of Regulatory Affairs / Office of Operations Immediate Office, FDA, USA
• Carmelo Rosa, Director, DIDQ, FDA, USA
  Recent Observations at Outdated Facilities and the Impact on Supply Chains

Controlling Pharma Data in the Cloud

• Rapidly deploy flexible, economical alternatives to building applications through cloud solutions.
• Meet both internal and regulatory expectations.
• Explore solutions through case studies for GMP implementation of CAPA and LIMS.

Moderators: 
Randy Perez, Director, Information Governance and Management, Novartis
Krishna Ghosh, Compliance Officer-CDER/Office of Compliance, FDA

Speakers:

• Boaz Gur-Lavie, Vice President, Finance, STARLIMS Corporation,
  Implementation of a Cloud-Based LIMS Solution
• Jason Silva, CEO, Sidus Data, USA
  Considerations for Successful Regulated Cloud Deployments
• Dimitrios Tsarouhtsis, Senior Quality Manager - Quality Control, Abbott Molecular,
  Implementation of a Cloud-Based LIMS Solution
• Keith Williams, Chief Executive Officer, GxPi, United Kingdom
  Cloud-Based CAPA

Industry Leading Special Events 

Meet the Press

A distinguished panel of regulators and industry experts will answer questions about how to drive patient safety, product quality and compliance throughout organizations, and how the pharmaceutical industry and regulatory agencies can work effectively in achieving these mutual goals. This thought‐provoking session is intended to open a dialog on issues and future direction and will be driven by industry, agency and audience questions. The expert moderators represent the pharmaceutical industry technical press, business and public media teaming to deliver a high value, engaging discussion.

Session Moderators:
Jeff Salkin, Host Direct Connect, Maryland Public Television
Bill Paulson, Editor-in-Chief, IPQ

Panel Members:

• Ilisa Bernstein, Pharm.D., J.D., Deputy Director, Office of Compliance, CDER, FDA, USA
• Joseph Famulare, Vice President, Genentech Inc, USA
• Richard Friedman, Associate Director, OMPQ, FDA/CDER, USA
• Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA, United Kingdom
• Cindy Salamon, Vice President, Global Quality Services, Bristol-Myers Squibb,

Industry-Led Hot Topic Discussion Forum

Industry leaders will answer questions directly from the audience. This your unique opportunity to have your questions, concerns, needs for clarity and opportunities for collaboration to be addressed directly by industry executives.

Session Moderator: 
Joe Famulare, Vice President, Genentech, Inc.

Speakers:

• Carol Bye, VP, Pharmaceutical Sciences, Quality Operations, Pfizer Worldwide Research and Development, United Kingdom
• Brian Lange, PE, Executive Director - Global Supply Chain, Merck & Co Inc, USA
• John Pinion, Head of Global Quality & Compliance Roche, Pharma Tech Ops, Genentech Inc, USA
• Andrew Skibo, Regional Vice President, Biologics-Supply, MedImmune/AstraZeneca, USA

Breakfast with the Regulators

This is an opportunity to hear from regulators and engage in open dialogue with them in a relaxed atmosphere.  The breakfast is included in the cost of event registration and is open to all delegates.  Limited seats available, be sure not to miss this exciting event!

Moderator: 
Steve Lynn, Senior Advisor to the Assistant Commissioner for Operations, Office of Regulatory Affairs/Office of Operations Immediate Office, FDA

Speakers:

• Ernie Bizjak, Compliance Officer, OHHS/FDA/ORA/OGROP, USA
• Brooke Higgins, Pre-Approval Manager/Investigator, OHHS/FDA/ORA/OGROP, USA
• Carmelo Rosa, Director, DIDQ, FDA, USA

Drug Shortage Panel Discussion

The conference will open with a spirited panel discussion led by the leaders of the committee that spearheaded the survey initiative. The panel will share issues identified using key data from the groundbreaking ISPE Drug Shortage Survey, and then discuss how shortages are impacting the industry. The All Conference Session will focus on potential industry solutions based on new FDA guidance.

Facilitator: 
Joe Famulare, Vice President, Genentech, Inc. 

Panel Members:

• Valerie Jensen, Associate Director for Drug Shortage, CDER, FDA,
• Zena Kaufman, Sr. VP Global Quality, Hospira, USA
• Stephen Mahoney, Senior Advisor Global Quality & Compliance, Genentech Inc, USA
• Francois Sallans, VP & Chief Quality Officer, Johnson & Johnson Pharmaceuticals, Belgium
• Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA

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