Training
Preconference and Postconference Training will be offered in conjunction
with the 2008 Conference. Click here
to Register!
Monday, 21 April 2008
Each session is 8:00 am - 5:00 pm (Lunch break 12:00 - 1:00 pm).
Basic Training: Good Laboratory Practice
Session Chair: Kimberly S. Frazier, Pfizer, Inc.
Speakers:
James J. Carignan, Vital Bridge, Inc.
Kimberly S. Frazier, Pfizer, Inc.
Sherry L. Garrett, Pfizer Animal Health
Target Audience:
This course is directed towards new GLP auditors, study directors, monitors,
coordinators, scientists, technical staff, supervisors and management involved
with GLP studies. The course could also serve as a refresher for more experienced
GLP auditors and study personnel.
Course Objectives:
The attendee will gain an understanding of the history behind the development
of the Good Laboratory Practice regulations. The attendee will gain a basic
understanding of the principles of the Good Laboratory Practice regulations.
The attendee will gain an understanding of the effects of non-compliance with
the Good Laboratory Practice regulations.
Course Description:
This full day basic training course offers a comprehensive and practical approach
to the Good Laboratory Practice (GLP) FDA and EPA (FIFRA and TSCA) regulations
and standards. The course includes examples and an exercise in the application
of the regulations. The course is designed for individuals associated with
toxicology, metabolism, residue, product chemistry and other studies conducted
under the GLPs and will be presented by knowledgeable speakers.
Advanced Training: Good Laboratory Practice
Session Chair: Jeanne deWard RQAP-GLP, Charles River Laboratories
Speakers:
James J. Carignan, Vital Bridge, Inc.
Jeanne deWard RQAP-GLP, Charles River Laboratories
Gregory Furrow, Charles River Laboratories
Guy H. Gardner RQAP-GLP, GlaxoSmithKline
James F. McCormack PhD, Charles River Laboratories Preclinical Services
Target Audience:
Quality Assurance professionals with two or more years of auditing experience
in the GLP environment
Course Objectives:
- Build on knowledge of the GLP regulations to enhance auditing and
inspecting skills
- Learn how to make audit reports more effective.
- Learn how to maximize
the positive effects of FDA inspections
Course Description:
You know the GLPs and you have learned how to audit. What is the next
level on the learning curve? This one-day session is devoted to interpreting
the ‘short and simple’ GLPs in an increasingly complex environment,
and becoming more effective in your role as the “Voice of GLP” in
your workplace. The session will focus on different approaches for auditing
data and final reports, “hot” or controversial topics in auditing,
and tips for writing effective audit reports. We will explore approaches
for managing FDA and EPA GLP inspections and ways to foster good relationships
among sponsors, contractors and subcontractors. This session is intended
for QA professionals with 2 years or more GLP experience.
Advanced Concepts in Computer Validation
Session Chair: Joseph A. Franchetti, JAF Consulting, Inc.
Speakers: TBA
This full-day training session is designed to take the QA Professional
to the next level of understanding validation challenges. This
course is designed for individuals who already possess an understanding
of basic validation concepts and are ready to move on to new topics
and
issues.
The first half of the day, we will focus on the practical application
of regulations in the laboratory setting and challenges of maintaining
systems and archiving data.
The second half of the day will focus on vendor audits. During
this session, we will present practical guidance from the point
of determining
whether
you need to conduct a vendor audit, setting up the site visit,
and knowing which documents to request for review (what's reasonable
and what type
of documentation is likely to be available). The break-out sessions
will focus on a mock exercise and review of vendor data and allow
you to apply
the techniques learned.
Course topics will provide attendees with information on:
• Maintaining the validated state;
• Retirement and decommissioning of computer systems;
• Electronic archiving;
• Laboratory systems – qualification vs. validation; and
• Vendor audit.
Current Topics in Good Clinical Practice
Session Chairs: Eileen Donovan RN, Cephalon, Inc.
John Coundouris, Tercica, Inc.
Speakers:
Carl Anderson, Biologics Consulting Group, Inc.
Pamela K. Barry, Cephalon, Inc.
Antonio Bumarch Jr., Cephalon, Inc.
Eileen Donovan RN, Cephalon, Inc.
Jacqueline M. Hevy RQAP-GCP, Amgen, Inc.
Jean Toth-Allen PhD, FDA/OC/OSHC/GCPP
Michael A. Trapani, The Biologics Consulting Group
Lee Truax-Bellows RQAP-GCP, Norwich Clinical Research Associates, Ltd.
Target Audience:
GCP Auditors with 2 or more years experience that are willing to participate
in interactive sessions.
Course Objectives:
- The attendee shall be able to distinguish between Fraud
and Misconduct
- The attendee shall gain experience in FDA Inspections of
a Sponsor
- The attendee will learn about the changes in the EMEA Directives
Course Description:
This interactive session will cover a variety of current GCP topics.
Topics will include an interactive session on Fraud and Misconduct,
Preparing for an FDA Sponsor audit, Auditing Around the World and Lessons learned when discontinuing a study Investigator
for non-compliance. Participants will be encouraged to share experiences
and new ideas with the attendees, with a goal of enhancing current GCP
knowledge and developing new approaches to auditing. Active participation
of the attendees
will be a key ingredient to the success of this course. The course will
be facilitated by auditors with significant experience and expertise
in their area of discussion.
BioAnalytical Training
Session Chairs: Maria T. Radino, HLS
Angie L. Harris, HLS
Speakers:
Irina B. Colligon
Anthony B. Jones, Taylor Technology, Inc.
Janet L. Emeigh MS, GlaxoSmithKline
Helen H. Lysy RQAP-GLP, PPD, Inc.
Victoria A. Spendel PhD, PAREXEL Consulting
Target Audience:
GLP auditors at all levels of expertise will benefit from this training
session.
Course Objectives:
The attendee will gain a better understanding of various bioanalytical
principles and guidance on how to audit laboratories as well as bioanalytical
validation and sample analysis study components.
Course Description:
The Bioanalytical Specialty Section will be presenting a full day
of training covering a variety of interesting topics for QA auditors
at all
levels of expertise. Agenda topics will include: Conducting GLP Compliance
Audits of Bioanalytical Laboratories, Science and Quality Assurance:
PK/QA, Understanding Linear Regressions, Instrument Validation/Qualification
Documentation Requirements, ELISAs and Auditing Them, and Improving
Efficiency and Effectiveness of Bioanalytical Auditing. Whether you are
an expert or a novice,
we encourage you to join us.
Study Director Training
Session Chair: Celeste A. Rose RQAP-GLP, RoseTECH Consulting
Speaker: Celeste A. Rose RQAP-GLP, RoseTECH Consulting
Target Audience:
This workshop is designed for:
- Study Directors and Principal Investigators
- Study Personnel who may become
Study Directors or Principal investigators
- Managers or QA professionals,
who wish to gain an increased understanding of the Study Director
role and GLP responsibilities
Course Objectives:
- Gain a greater understanding of GLP regulations that apply to their
roles and responsibilities
- Locate citations pertaining to specific GLP
requirements
- Learn how to effectively and compliantly execute quality
GLP studies
- Generate compliant study protocols, study file documentation,
reports
- Apply newly learned skills and knowledge to problem solving,
mitigation, and prevention
Course Description:
This workshop is designed to provide the participant with a thorough
understanding of the GLP requirements and responsibilities of the Study
Director role, as well as soft skills and writing skills which are key
for effective quality study conduct. The session will cover study compliance
and the importance of good documentation, effective writing, and study
reconstructability.
Click here for the preliminary meeting schedule
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