Changing the Quality Culture

A sustainable global quality culture is foundational in providing high quality products to global customers, our patients. Building a global quality culture begins with proactive broadening and development of individual's mindsets and beliefs at the core of every manufacturing organization. Appropriately designed quality strategies and Quality Management Systems that comply with global regulations and regulator expectations are essential investments to build collaborative cultures whereby everyone owns quality. 

Industry survey results provide an insightful view of the state of quality in the industry today in the current globalization environment and increased guidance and high regulator expectations. These discussions  explore quality at several levels in a global regulatory environment and explore how quality is defined by the patient and the need for global changes to provide the most value to our patients in the regulatory space. 

Greg Guyer, PhD,  Senior Vice President, Global Quality, Merck Sharp & Dohme
Anthony Mire-Sluis, Vice President, Corporate, Product and Device Quality, Amgen, Inc.
G.K. Raju, PhD, CEO, Light Pharma, Inc.

Quality Systems

The ability of a company to consistently produce a dependable drug is rooted in the effectiveness of their quality system.  This recording underscores the essential role played by senior management to create a proactive environment that assures an ongoing state of control and continual improvement.  Speakers discuss how a strong quality culture, sound science, and quality risk management throughout the lifecycle (consistent with concepts in ICH Q10) assures that an organization makes daily decisions in accord with a quality assurance mindset.  The importance of designing systems and operations to prevent manufacturing problems and quality failures, and to assure robust detectability of process variation is addressed. This important discussion also addresses the benefits of modernization and innovation, as well as the ongoing challenges of supplier (CMOs, ingredients) management.

Robert Rhoades, Vice President, Quintile Consulting
Ian Thrussell, Head of Inspections, WHO and Expert Inspector, MHRA

Manufacturing in the Future

As we look to the future, the pharmaceutical industry will be faced with a number of challenges and opportunities.  Some of the issues for the new millennium include: green manufacturing, disposable medical products, innovative technologies, new approaches to method and technology transfer over the lifecycle of a medical product, and continuous manufacturing.  The purpose of this discussion is to initiate the dialogue on the future of manufacturing in the medical product sector by:  1) addressing continuous manufacturing which has the ability to process materials to a defined end state without any process interruptions but has some uncertainties (e.g., risks associated with manufacturing in a quality by design paradigm); and 2) discussing the concept of innovation through green manufacturing within the medical products arena while maintaining efficient manufacturing processes.

Thirunellai Venkateshwaran (TG), Director, Pharma Technical Regulatory, Genentech, Inc. 
Vilayat Sayeed, Supervisory Chemist, CDER, FDA

Quality Risk Management Implementation

The ICH guideline on Quality Risk Management (ICH Q9) was approved eight (8) years ago already. Concepts on decision making are discussed to manage uncertainty in a risk acceptance decision. This session discusses how the link of risk and knowledge management can lead robust process understanding.

Gregg Claycamp, Senior Scientists for Risk Analysis and Decision Analysis, CVM, FDA  
Emma Ramnarine, Senior Manager, Genentech, Inc.
Markus-Peter Mueller, Head Quality Management Inspectorates, Swissmedic

Cell Therapy Innovations

Cell therapy represents a separate therapeutic platform technology to that of the current three pillars of healthcare: pharma, biologics and medical devices.  This discussion explores the challenges regulators and industry face as novel cell therapy treatments develop and make their way to market.  Topics include:

• Cord versus embryonic cells
• “Real time” Release testing
• Autologous versus allogeneic cells challenges
• Raw Material Qualification and Management
• Scaling up versus scaling out

Kimberly Benton, PhD, Deputy Director, CBER, FDA
Jean Stanton, Director R&D Compliance, Johnson & Johnson
Alice M. Varga, Vice President Regulatory Affairs and Quality Assurance, Oxigene

CMO

Contract Manufacturing is an emerging discipline in the pharmaceutical industry.  This recording provides an overview of Contract Manufacturing from a variety of perspectives:  The contract giver, the contract provider and an independent third party viewpoint.  This session discusses the challenges clients and CMOs face with respect to establishing robust Quality Agreements and Quality Systems that govern their relationship.

EJ Brandreth, PhD, Vice President, Quality and Regulatory, Althea
Christopher Masterson, Senior Director of Quality, Cubist Pharmaceuticals
Allan Coukell, Director of Medical Programs, Pew Charitable Trusts/Pew Health Group

Quality Agreements

Increasingly, competitive pharmaceutical manufacturing relies on business relationships with internal and external entities.  Examples of such entities include, contract manufacturing, packaging, and testing organizations, and API suppliers.   Site specialization and globalization have led to a manufacturing paradigm that facilitates competitive advantages through a diversified and geographically dispersed supply chain.  This session discusses the expectations and ideals of internal and external quality agreements and proper management and execution of these agreements to achieve consistent, high quality drug products.  In addition, addresses how to manage multiple Quality Agreements that may control the manufacture of a product.

Kenneth Drost, Executive Director, Head of North America Quality, Amgen, Inc.
Paula Katz, Senior Policy Advisor, CDER, FDA

Emerging API Guidance

GMP expectations for API has steadily evolved over the last several years as ICH Q7 and API Starting Material requirements have been debated at length, ICH Q9 and Q10 have been approved, and now ICH Q11 has recently been approved as a step 4 document.  These evolving guidelines address new or updated concepts such as risk management, process development, control strategy and process validation.  This session discusses the latest development and expectations regarding Q11 for API manufacturing and the challenges they present to industry.

Betsy Fritschel, Director, Johnson & Johnson
Patrick Swann, Supervisory Pharmacologist, CDER, FDA
Timothy Watson, PhD, Research Fellow, Pfizer, Inc.

International Compliance Update

With the globalization of the pharmaceutical industry, FDA continues to conduct more inspections outside of the United States.  This session provides highlights from FDA’s international surveillance programs, review trends, and discuss case studies.

Carmelo Rosa, PhD, Director for the Division of International Drug Quality,  CDER, FDA
Daniel Walter, Branch Chief, Division of Enforcement B, Office of Compliance, CDRH, FDA
Robert McElwain, Consumer Safety Officer, CBER, FDA

Excipient Best Practices

This session describes the basic requirements on GMP for Excipients described by the internationally recognized guideline from IPEC-PQG. Different approaches for sharing audit results on excipient suppliers are shown (e.g. IPEC, Rx360, APIC). Special attention is given to the selection of excipients regarding safety aspects and pitfalls detected in submissions.

Janeen Skutnik-Wilkinson, Director, Quality & Regulatory Policy, Pfizer, Inc.
Jeffrey Medwid, PhD, Senior CMC Review Chemist, CDER, FDA

Investigations

Failure to conduct adequate investigations continues to be a compliance concern and one of the top 10 inspectional 483 observations by the FDA. Thorough investigations leading to an understanding of the root cause will enable implementation of appropriate corrective actions and preventive actions (CAPA). Additionally, knowledge management and effective, careful communication are also key elements when performing investigations.  Industry case studies and the regulatory expectations are discussed.

David Perkins, Director Quality Management, Abbott Laboratories
Kristen Evans, Executive Director, Amgen, Inc.
Steven Lynn, Office Director, OMPQ, CDER, FDA

Combination Products

Innovation and advances in technology over the last two decades have blurred the traditional lines with how products are viewed and regulated.  A one size, one type, one U.S. FDA Center fits all approach is not necessarily the norm, especially if the product meets several definitions be it drug, device or biologic.  U.S. FDA established the Office of Combinations Products in 2002 to serve as focal point for issues relating to combination products and to coordinate review of these products in a timely manner.  
This session includes discussions on:

• Interaction with the FDA's Office of Combination Products; explain regulatory authority and agreements between the Centers
• Explain and give examples of Primary mode of Action
• Talk about Impact on clinical trials
• Provide information on using single or multiple pre-market applications
• Discuss Appropriateness of cGMP (Drug and/or Biologic) and/or Quality Systems (Device)

Patricia Love, Deputy Director, Office of Combination Products, OC, FDA
Donna French, PhD, Senior Director, PTDU Device Development, Genentech, Inc.

Compliance Update

This session features the Compliance Directors from the FDA’s Centers and Office of Regulatory Affairs who provide a short update on current hot topics in the compliance and enforcement areas.  Significant FDA483 observations and other regulatory actions are covered.  Ample time is provided for these Directors to address questions.

Panel Participants:

• CBER: Mary Anne Malarkey, Director, Office of Compliance, FDA
• CDER: Douglas Stearn, Deputy Director for Policy and Analysis, FDA
• CDRH: Steven Silverman, Director, Office of Compliance, FDA
• CVM:  Martine Hartogensis, Deputy Director, FDA
• ORA: Armando Zamora, Acting Director, OE, FDA

Center Initiatives

This session includes discussion from some of the agency's leaders with regard to their Center’s current and future initiatives.

Panel Participants:

• CBER: Christopher Joneckis, Sr. Advisor - CMCs, FDA
• CDER:Richard Friedman,Associate Director, OMPQ, CDER, FDA
• CDER: Steven Lynn, Office Director, OMPQ, CDER, FDA  
• CVM: Martine Hartogensis, Deputy Director, FDA
• ORA: Howard Sklamberg,  Deputy Associate Commissioner for Regulatory Affairs, FDA

Contact

Jason E. Brown
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org