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Clinical Auditing Forum - Day 1

Wednesday, June 15, 2011


7:00 am Registration and Morning Coffee 

8:00 Welcome & Chairperson’s Opening Remarks


8:15 What Do We Know? A Review of Publically-Available Information and Resources to Develop FDA Inspection Readiness

Barbara van der SchalieBarbara van der Schalie, Clinical Training Manager, Clinical Monitoring Research Program, SAIC-Frederick

Although the CFRs that guide clinical research are rather vague, the FDA provides documents that are publicly available that indicate their focus in compliance inspections. In this presentation we will first review the recent FDA Warning Letters, both titled and untitled, that provide a good indication of the areas of greatest scrutiny and non-compliance. Then, we will discuss the FDA Inspector Compliance Manuals, which provide a blueprint for FDA inspection readiness as they specifically enumerate what should be reviewed during an inspection. The FDA Inspection Compliance Manuals are essential to developing an integrated view of the FDA’s focus in compliance inspections. In order to establish or maintain a state of FDA Inspection Readiness, a robust, dynamic plan is essential. This presentation will provide:

  • A review of relevant FDA Warning Letters from the last three years
  • The critical elements of an FDA Inspection Readiness Plan
  • A blueprint for inspection readiness design and implementation


9:00 Strategies for Developing a Comprehensive and Compliance-Focused Auditing Program

William KitchensWilliam H. Kitchens, Partner and Chairman of the Healthcare and Life Sciences Practice Group, Arnall Golden Gregory LLP, and Adjunct Professor, Emory University School of Law

This presentation provides an overview of how to build a culture of compliance surrounding the conduct of clinical trials. While no compliance program can ever prevent all regulatory infractions, there are certain critical factors that should be considered in the design and implementation of an effective compliance program. In this session, we will examine basic compliance principles and the due diligence steps a clinical trial site should take to prevent and detect problems that could trigger FDA enforcement actions. Participants will gain knowledge about the following:

  • A basic understanding of compliance auditing and its importance
  • Recent trends in FDA sanctions against clinical sites
  • How to promote an organizational culture that encourages a commitment to compliance
  • Key components of an effective compliance program
  • How to respond effectively to an FDA investigation of a clinical trial site


9:45 Networking Coffee Break and Exhibit Viewing


10:15 CRA Compliance Committee: One Sponsor’s Approach to Ensuring Compliance

Janice BoydJanice Boyd, Principal CRA, Clinical Study Operations, Abbott Vascular

The Abbott Vascular Field-CRA Group has initiated a CRA Compliance Committee to assist in ensuring that consistent practices among Field CRA staff are implemented during the conduct of clinical trials. Specifically, we will review compliance to departmental operating procedures and standards. In addition, potential training needs for both clinical site personnel and FCRA staff will be suggested to help improve the overall quality of work. This initiative is an innovative, proactive approach to compliance that few companies have in place. The audience will be introduced to a proactive approach to compliance that is a positive experience among peers that helps to ensure compliance at our sites, promote consistency in our processes, and identify training opportunities for CRAs and sites.

11:00 Suspected Clinical Non-Compliance: Trials and Tribulations

James Tripp, Associate Director, Compliance & Training, Regeneron

With a significantly increased number of Regulatory Agency Inspections, it is even more critical to ensure that processes exist which allow for escalation and immediate remediation. One area of interest across the industry is how to increase awareness and communication, and to ultimately decrease the incidence of clinical noncompliance. That being said, clinical noncompliance is a serious matter and should be dealt with urgently, with good documentation of any corrective and preventive actions. This presentation will focus on the general awareness (initial and on-going training) of compliance/noncompliance, a proposed procedure for managing suspected clinical noncompliance, and illustrate how all relevant parties are informed via a “GCP Compliance Committee” chaired by the Head of Clinical Compliance and Training with senior management membership.

11:45 Sponsored Luncheon (Sponsorship Opportunity Available) or Lunch on Your Own

1:00 pm Investigator Meetings: Are They Really Listening?

Barbara OsinskiBarbara Osinski, Manager QC GCP Compliance and Training, Clinical Development, Grunenthal USA, Inc.

Investigator Meetings are considered the first line of training for Principal Investigators when it comes to Good Clinical Practice and regulatory responsibilities. Standing in front of the audience quoting regulations is not the way to gain their attention and ensure training is successful. Investigator meetings are taught in a boiler plate way, most times with the principal investigators taking calls and checking emails. Signing an attendance sheet does not ensure compliance when the information delivered was not remembered. It’s time for those charged with presenting this important information to do so in an effective and streamlined way that will ensure success in delivery. Interactive, study-specific, regulatory-based training will achieve the number one objective of understanding the regulations in the context of the study being conducted. In this session, we will explore an alternative way of conducting GCP training at investigator meetings that is interactive, thought-provoking, and even enjoyable!

1:45 Determining Root Cause and Developing Effective Corrective and Preventative Actions (CAPA)

Nikki ChristisonNikki Christison, Director, Clinical Operations, Centerphase Solutions, Inc.

Every year hundreds of clinical trials are in a state of needing “rescue”. By identifying the root cause of the study issues, a carefully developed plan can be implemented to systematically analyze and address each problem without incurring greater risk, loss of quality in data, or jeopardizing relationships with investigators, sites, and colleagues. In addition to addressing the immediate problem, an analysis of the cause of the issue(s) will allow better understanding and ensure development of systems, training, and documentation as a preventative action to improve processes in the future. The discussion of root cause and how to develop an effective corrective action plan will be presented around a sample study of a trial in jeopardy with an analysis of the “big picture” challenges, determination of the root cause, and hands-on development of an action plan with audience participation. We will discuss how to prevent problems from evolving with careful protocol design, feasibility analysis, selection and training of teams, and appropriate documentation.

2:30 Development and Implementation of GCP SOPs – Latest Trends

Marta I. Jimenez-Aquino, M.B.A., Process Expert, OEX Consulting, Inc.

“Innovation in process – how things get done in an enterprise – is as important as innovation in the products a company sells” – Louis V. Gerstner Jr., Chairman and CEO of IBM. Two decades ago, this key principle guided Mr. Gerstner during a period of great challenges at IBM and helped him create the vision that transformed the company into a successful enterprise. Today, pharmaceutical and biotechnology companies face similar challenges. Quality, compliance, and innovation are not possible unless people are doing the right things right every time. This requires a system of standard operating procedures (SOPs) that are accurate, compliant with applicable regulatory requirements, and up-to-date. SOPs must be user-friendly, reflect cross-functional boundaries and interactions, and ensure consistency within and across related processes. From the initial assessment and gap analysis of a company’s GCP SOP suite to the development and rollout of SOPs and SOP training, participants will learn about current industry standards, regulatory expectations, and latest trends and methodologies. They will benefit from the discussion of real world case studies that illustrate best practices, common pitfalls, and innovative approaches in GCP areas.

3:15 Networking Refreshment Break and Exhibit Viewing


3:35 Implementing a Quality Systems-Based Approach to GCP Compliance

Amnon EylathAmnon Eylath, Director, Quality, ARIAD Pharmaceuticals

In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted. In the GMP and GLP domains, this approach has led to more effective and efficient maintenance of compliance. Your speaker will describe the GMP Quality System, and how, in a similar manner, a GCP Quality System can be utilized by ensuring the proper establishment of investigator oversight and documentation; IRB oversight; sponsor monitoring; corrective and preventive action (CAPA) execution; IP controls; and Clinical Staff and lab qualification. Your speaker will present proposals for adopting this approach at clinical sites, as well as the role of the sponsor in establishing internal GCP quality systems, and ensuring compliance at the sites and CROs. The topic of auditing from a Quality Systems-Based Approach will also be discussed. Your speaker will also give real-life examples of failures to deploy and implement these systems properly based on recent warning letters from FDA.

4:20 Quality Risk Management: The Comprehensive Quality Management System

Kenneth D. Schiff, Proprietor/President, Quality Risk Management Associates, LLC

What was accepted some years ago by regulatory agencies – an auditing approach to GCP compliance – is no longer acceptable. Implementing a Quality Systems-Based Approach to GCP Compliance is the answer to regulators’ new expectations. The wealth of information from the centers to the sponsors’ databases, facilitated by EDC, can be overwhelming. Quality Risk Management (QRM) provides study managers with a prioritization of sites with a risk ranking, identifies the weaknesses in the processes at the sites, and ensures clinical QA comprehensive oversight over all the studies. A recent CTTI (Clinical Trial Transformation Initiative) meeting facilitated by Duke University with representatives from regulators, industry, and sites focused exactly on this topic. Janet Woodcock, former FDA commissioner, clearly demanded a QRM based approach to GCP compliance and management. Your speaker will discuss the F. Hoffman-La Roche QRM approach to QRM, and how this paradigm change can be made a reality.

5:05 Pharmacovigilance Audits from a Sponsor’s Perspective

Michael G. Duncan, Senior Specialist, Global System Quality Assurance, Johnson & Johnson

This session will provide an overview and discussion of the process of performing a Pharmacovigilance audit. The entire process, beginning with selecting systems or departments on a risk-based approach within an organization for auditing, will be reviewed. Audit preparation, conduct including sampling, and evaluating compliance to regulations will be discussed. Specific topics to be covered include: Individual Case Safety Reports, special circumstances (pregnancy, overdose, misuse/abuse, lack of effect), aggregate reports, and the role of the QPPV. In addition, inspection readiness will be discussed, including examples of Pv functions commonly cited by regulatory health authorities. This session will also provide opportunity to ask questions concerning specific requirements for the collection evaluation and reporting of safety information.

5:50 Reception and Exhibit Viewing (Sponsorship Opportunity Available)

6:50 Close of Day One


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