FDA, MHRA, PMDA, & Industry Leaders Present on Data Integrity, Quality Metrics, & New Technologies in Global Manufacturing Environment

Considered to be the paramount conference in the pharma industry, the 2018 ISPE Quality Manufacturing Conference provides the latest in:

  • Leading-edge approaches in regulatory harmonization
  • Quality and manufacturing potential
  • Facilities and equipment innovation and evolution

Gain expert insight from 90+ international regulatory and pharma industry leaders addressing the implementation of new technologies in the global manufacturing environment and the latest trends and challenges in quality manufacturing.


Regulatory Speakers

Mark Birse
Mark Birse
Deputy Director-Inspection, Enforcement & Standards, Head of Inspectorate
MHRA
Richard L. Friedman
Richard L. Friedman
Deputy Director, Science and Regulatory Policy
CDER/FDA
Charles F. Jewell
Charles F. Jewell
CMC Reviewer, Office of Pharmaceutical Quality
CDER/FDA
Paula Katz, JD
Paula Katz, JD
Director, Manufacturing Quality Guidance and Policy Staff
CDER/FDA
Yoshihiro Matsuda, PhD
Yoshihiro Matsuda, PhD
Senior Scientist for Quality
PMDA
Helen YeJin Saccone, CDR, PharmD
Helen YeJin Saccone, PharmD
Associate Director, Global Regulatory Policy, Office of Compliance
CDER/FDA
Lawrence X. Yu, PhD
Lawrence X. Yu, PhD
Deputy Director, Office of Pharmaceutical Quality
CDER/FDA
Mr. Alonza Cruse
Mr. Alonza Cruse
Pharmaceutical Quality Program Director,Office of Operations
CDER/FDA
Giuseppe Randazzo
Giuseppe Randazzo
Acting Office Director, Office of New Drug Products
CDER/FDA
Obinna Ugwu-Oju
Obinna Ugwu-Oju
Branch Chief, Office of Surveillance
CDER/FDA
Stephen Miller, PhD
Stephen Miller, PhD
CMC-Lead, Office of Product Quality
CDER/FDA

Get Answers to Your Most Pressing Questions On:

  • Global Regulatory Harmonization
  • Data Integrity
  • Quality Metrics
  • Starting Materials & Q11
  • Lifecycle Management & Q12
  • Quality Agreements
  • Patient-Centric Specifications
  • Tech Transfer
  • Process Validation

Hear from Timothy Watson, Program Chair, on why you should attend the 2018 ISPE Quality Manufacturing Conference.


Featured Plenary Sessions

  • FDA on Future Direction of Healthcare through Quality Manufacturing
  • A Global View of Quality – Regulatory and Industry Perspectives
  • Patient-Centric Specification
  • Lifecycle Process Validation - the Ongoing Quest for Process Excellence
  • Interactive International and US FDA Regulatory Forum

View Agenda

Track Highlights


Regulatory Quality Facilities
International Regulatory Convergence Quality Agreements Contamination Control Strategies
Challenges of API Starting Materials Human Error Prevention Ensuring an Efficient, Quality-Centric Technology Transfer in an Era of Increased Complexity
Accelerated Development Quality Metrics Data Integrity Beyond the Laboratory
Lifecycle Management Key CMC Considerations for a Successful Product Approval GMP for Continuous Manufacturing

Who Should Attend?

The 2018 ISPE Quality Manufacturing Conference is designed for a global audience of pharmaceutical professionals from pharma, bio, and generic companies and regulatory agencies, including those at the executive and management levels, pharmaceutical scientists and engineers, manufacturing supervisors, and suppliers.


Benefits of Attending

This event will provide the opportunity to:

  • Interact with experts in the industry and regulatory agencies to stay abreast of current and evolving topics that are essential to the success of the pharmaceutical supply chain
  • Gain insight into the current perspectives of regulatory agencies, manufacturing, and pharmaceutical quality
  • Benchmark on manufacturing, quality and regulatory issues affecting the industry
  • Gain insights on the quality and regulatory aspects of emerging technologies, and increasing supply chain complexities

Program Committee

Timothy Watson Photograph
Chair: Timothy Watson, PhD
Research Fellow/CMC Advisory Office
Pfizer, Inc.
George Millili Photograph
George Millili, PhD
Senior Principal Technical Advisor
Genentech (A Member of the Roche Group)
Dave Doleski Photograph
Dave Doleski
Quality and Manufacturing Track Director
Compliance Head for Biologics Quality Operations
Sanofi
Betsy Fritschel Photograph
Betsy Fritschel
Regulatory Track Director
Director Quality and Compliance
Johnson & Johnson
Bob Iser Photograph
Bob Iser
Equipment and Facilities Track Director
Vice President
Regulatory Consulting Services
Parexel International
Thomas Cosgrove, JD Photograph
Thomas Cosgrove, JD
Partner
Food, Drug, and Device Group
Covington & Burling LLP