Program:
BARNETT INTERNATIONAL’S
Increase GCP Compliance & Create Usable Global Standard Operating Procedures
Global SOP Systems
Business Process, Implementation, Training & Follow-Up
September 13-14, 1999 Sheraton Premiere, Tysons Corners, VA
First Time for Unparalleled Industry Representation
Zeneca Pharmaceuticals
Smith-Kline Beecham
Amgen
Daiichi Pharmaceuticals
Hoescht-Marion Roussell
Chiron Corporation
Purdue Pharma
Novo Nordisk Pharmaceuticals, Inc.
Janssen Research Foundation
COVANCE PAREXEL
Quintiles
Validation & Training Services
Hilltop Research
The Clinical Innovation Group
NCGS Associates, Inc.
Barnett International
Phoenix International
Acquire Expertise of Specific Case Studies:
Going Global with the SOP Process
Zeneca Pharmaceuticals
SOP Writing and Implementation for GCP and ICH Compliance
Novo Nordisk Pharmaceuticals, Inc.
Changing SOP Issues in a Rapidly Expanding Pharmaceutical Company
Purdue Pharma
Streamlining the SOP Process to Facilitate the Update and Revision of SOPs
Daiichi Pharmaceuticals
Learn from Leading Experts in the Global SOP Process
Negotiating, Reviewing & Approving SOPs in a Global Environment
Successful Use of Global SOPs
Complete “How-To” Session: Computer Validation SOPs
Maximizing Selection and Planning Efforts for Benchmarking the SOP Process
How to Implement Follow-up in a Global Environment
Key Social Processes for SOPs with High Business Impact
Writing Global SOPs with Maximized Compliance and Minimized Risk
Plus:
Extended, Interactive Session with In-Depth Insight into New Innovations in Training:
Developing an Effective Training Program & Encouraging User Acceptance and System Feedback
Barnett International is approved by the American Council of Pharmaceutical Education as a provider of continuing education credits.
September 13, 1999
8:00 Breakfast & Registration
8:30 Conference Expectations & Chairperson’s Opening Remarks
Bella Englebach, Director, Consulting, Training and Development, Barnett International/COVANCE PAREXEL
8:45 Globalizing SOPs for a Global Environment
Bella Englebach, Director, Consulting, Training and Development, Barnett International/COVANCE PAREXEL
A tidal wave of globalization has swept drug and device clinical researchers into a new world -- partly unified and still very diverse. How are companies responding as they document and implement their clinical research procedures? We'll look at the drivers for globalization and the struggles still to be overcome.
9:30 Case Study: Going Global with the SOP Process
Phyllis Piser, PhD, Manager, Medical Research and Communications Group, Professional Development, Zeneca Pharmaceuticals
Learn how one company was able to go global with the SOP process, what problems were encountered and how to avoid those problems. Apply their successes toward your company’s efforts at globalizing your SOP process.
10:15 Break
10:30 Negotiating, Reviewing & Approving SOPs in a Global Environment
Kathy Schoonover, Clinical Operations Manager, Hoescht-Marion Roussell
Issues to be addressed include:
Factors that facilitate or hinder Global SOP development (legal, regulatory, organizational)
Negotiating the draft SOP: optimizing information gathering, streamlining the process
SOP review/approval strategies in a global environment
11:15 CASE STUDY: SOP Writing and Implementation for GCP and ICH Compliance
Karen Hopkins, RN, MS, Director, Clinical QA, Regulatory Affairs, Novo Nordisk Pharmaceuticals, Inc.
This presentation will address some of the challenges and rewards encountered by a global team writing corporate drug development SOPs including and combining US GCP requirements, ICH GCP requirements and industry standards. Also, making the SOPs user friendly and conducive to conducting clinical trials expeditiously.
12:00 Lunch
12:45 Writing Global SOPs with Maximized Compliance and Minimized Risk
Wayne Coen, Associate Director or Regulatory Affairs and Head of Quality Assurance, Daiichi Pharmaceuticals
This presentation covers those issues that need to be considered BEFORE global SOPs are written. It is not enough that writers know the regulations. Other factors are at least equally important. Heightened awareness of these factors will enable writers to create SOPs that can be understood and followed regardless of location, regulation or medical practice. This session will provide insight into practices acceptable to most regulatory bodies while minimizing risk.
1:30 Effective SOPs: Ensuring Compliance from the Beginning
Norina J. Orton, MS, RAC, Director of Quality Assurance, The Clinical Innovation Group – MUSC Foundation for Research Development
This session will provide guidance in designing user-friendly SOPs that will actually be taken off the shelf and used. It will demonstrate steps to ensure that SOPs are complete, effective and east to implement, while discussing the importance of the team approach to establishing SOPs.
2:15 Break
2:30 CASE STUDY: Changing Issues in a Rapidly Expanding Pharmaceutical Company
Joel Wolf, Assistant Director of Regulatory Compliance, & Kristen Friedman, Purdue Pharma
In a company that is expanding in product development and distribution, SOPs that once clearly defined a procedure can become a hindrance due to changing roles of employees and the need for different procedures for different products. Revisions and updates to existing SOPs come slowly when groups aren't sure of their changing roles in SOP development. In addition, distribution of new and updated SOPs to an ever-growing employee pool is incredibly labor intensive and prone to error. In light of this, SOP management is in the midst of change at our company. We will be revising our SOP Committee structure to attempt to make clear each groups' role in SOP development, globalize procedures by redefining the groups who will have input into our SOPs and rely more on Guidance Manuals. Finally, we will cease distribution of paper SOPs to the majority of the department's workforce and instead will make SOPs available electronically.
3:15 Key Social Processes for SOPs with High Business Impact
Annette Horner, Vice President, Consulting Operations, Barnett International/COVANCE PAREXEL
Experienced professionals in the industry often think of an SOP only as a written document; something utilitarian required by government regulation. Yet, the process of developing these documents is an excellent way to build consensus on business process, as well as to capture and disperse expert knowledge within the organization. This session outlines key social processes to build into the SOP project to enhance the overall business impact of the effort. This session will provide case examples of how to:
Ensure that SOP development taps knowledge from expert practitioners
Obtain consensus on ill-defined business processes
Standardize business practices across multiple user groups
Obtain buy-in from SOP users at all levels
Raise levels of SOP compliance
4:00 Successful Use of Global SOPs
Bella Engelbach, Phyllis Piser, Elaine Price, Jay Miller, Annette Horner
Get questions about your SOP project answered with this interactive session. Audience participation will drive this question and answer format with direction from the panel participants. Structured facilitation will help all attendees receive the tools necessary to manage their SOP project - global or local. Come prepared with specific questions and add to your list as the conference progresses!
5:30 Close of Day One
September 14, 1999
7:30 Coffee
8:00 A Global Approach to SOP Automation
Elaine S. Price, President & CEO, Phoenix Systems
Production facility documents are critical to ensuring a successful and FDA compliant process. In a manufacturing environment SOPs (Standard Operating Procedures) are critical to ensure that all documents utilized for a process are in fact correct, and reflect the most recent version of that document. There is a formal approval process put in place to support this effort in any regulated environment. The added feature of integrated electronic signatures for the approval process has proved to be a significant advantage.
The benefits of a properly designed SOP solution is the ability to support multiple countries and/or divisions. Topics included in this session are:
The base architecture required to support the SOP solution
Streamlining the routing and approval process
Fast and easy access to document history
Significant decrease in administrative efforts
Improve the quality process
Enhance document security through signature capture
8:45 Evaluating Draft SOPs for Global Impact
Linda K. Reger, Clinical Operations, Quintiles
SOP writing involves cross-functional, if not global, review. This session
will examine how to evaluate draft SOPs. Consideration will be given to the
5 C's: clarity, consistency, content, culture, and compliance.
9:30 Complete “How-To” Session: Computer Validation SOPs
Babak Ghayour, President, Validation and Training Services
Purpose for computer validation SOPs and why they are needed
Determining which SOPs should be prepared and which can be “reused”
Handling external and internal services
Roles and responsibilities
10:15
Break
10:30 QA’s Role: The Company’s Success through the SOP Process
Sharon Joel, Manager, Clinical Research Quality Assurance, Donna Sullivan, Manager, Clinical Research Quality Assurance, Janssen Research Foundation
This presentation will discuss the axel of the process for reviewing SOPs that QA should use before they become permanent SOPs. Also, it will discuss verifying that the SOP process is what is being used throughout
11:15 Developing “Usable” SOPs for SMOs, PPOs, and Individual Sites
Karen S. Sargent, Director of Q. A. and Regulatory Affairs Corporate QA, Hill Top Research, Inc.
Standard operating procedures (SOP) are essential to assure consistent and reliable study conduct by many individuals regardless of their proximity to each other (same office or different offices). While SOPs are excellent training and marketing tools, the intend and scope should permit individuals with accepted training and experience in a discipline to readily adapt their skills to the methods and customs described in an SOP. This session will discuss the importance of developing “usable” standard operating procedures for Site Management Organizations (SMO), Physician Practice Management (PPM) organizations and individual sites.
Why are SOPs valuable to an investigator?
How do SOPs improve staff training?
Why are SOPs a value to the customer?
What happens with the client’s SOPs conflict when the site SOPs?
12:00 Luncheon
12:45 CASE STUDY: Streamlining the SOP Process to Facilitate the Update and Revision of SOPs
Fernanda Camacho, Senior Manager, R&D Operations, Daiichi Pharmaceuticals
This presentation will highlight the SOP format that has been chosen by Daiichi to make updating and revising SOPs a simpler task. The presentation will also compare the SOP formats of the three sites in the U.S., England and Japan to highlight the differences and similarities among the three sites.
1:30 Maximizing Selection and Planning Efforts for Benchmarking the SOP Process
Nancy Snowden, President of NCGS and Associates, Inc., Charleen Pagel-Jue, Director of Operations at Chiron Corporation
This talk will address:
Choosing the Right Benchmarking Partners, including: comparison of a small group of companies with similarities and disparity in their size (big pharma and smaller biotech), product focus (biologic and pharmaceutical). Company committed to true process improvement and not just an intellectual exercise and proper resource allocation.
Choosing the Right Sample Size for Comparison
Proper Planning Prior to the Main Reviews, including: establishing goals and objectives, establish time commitments upfront and for follow through, choosing the right representatives from each company, desire of participants to maintain re-review process at reasonable intervals (annually or every other year).
Confidentiality and why it is not an issue in this model
Choosing the Right Venue: neutral ground and rotation of hosts
2:15 How to Implement Follow-up in a Global Environment
Seth Whitelaw, Regulatory Compliance Officer, Smith-Kline Beecham (invited)
This session will address global issues in SOP follow-up, including:
Evaluating the questions surrounding follow-up
Finding the correct answers
Implementing this important function in the SOP process
3:00 Break
3:15 Successful Use of a CRA Mentor Program for Field Training on GCP SOPs
Jay Miller, Associate Director, Clinical Affairs, Amgen
Practical hands-on experience in dealing with real-world clinical trial conduct is an essential element in the development of Clinical Research Associates (CRAs). One-to-one field training allows CRAs to hone the methodological and analytical skills they learn in class and practice them at the clinical site. The CRA Mentor Program is designed to allow CRA Trainees to observe CRA Mentors performing SOP-required tasks that support GCP. Subsequently, the CRA trainees perform the tasks themselves under guidance of CRA Mentors (See-one and Do-one).
4:00 INTERACTIVE SESSION: Developing an Effective Training Program & Encouraging User Acceptance and System Feedback
Robert F. Walsh, Team Leader, Training and Technical Publications, Phoenix Systems Integration, LLC
As the evolution of technology brings us closer to a truly paperless environment, we are faced with the daunting task of training our work force to embrace the new, electronic workflow process. However, far too many Electronic Document Management System (EDMS) solutions implemented by corporations today fail to take into account the importance of proper training for the end user. Time has proven that without user acceptance, any EDMS solution is doomed to failure.
The benefits of a properly designed and implemented training program expand far beyond mere knowledge transfer. An effective training program will limit the culture shock of new implementations, create a sound basis for internal Knowledge Management, encourage end user acceptance and system feedback, and ensure the necessary environment for system validation.
The topics will include:
User resistance to change, and the way to overcome it
Designing a training program that creates ownership
Training and RAD: the evolution of a client-responsive system
Effective interactive training techniques
The importance of customer evaluations and feedback
Following up: ensuring end user acceptance
5:30 End of Conference
Registration :
$1,695 (for discount information, contact tracy.trauger@parexel.com)
Deadline for Abstracts: N/A
Email for Requests and Registration: customer.service@parexel.com