Training
Preconference and Postconference Training will be offered in conjunction
with the 2008 Conference. Click here
to Register!
Sunday, 20 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.
Introduction to Principles of Computer Validation for the QA Professional
Session Chair: Joseph A. Franchetti, JAF Consulting, Inc.
Speakers: TBA
This full-day training session is designed to provide the QA Professional
with an overview of the validation process, regulatory expectations
and auditing strategies. Course attendees will participate in
break-out sessions
and exercises to enhance their level of understanding of the
concepts presented.
Course topics will provide attendees with information on:
- Understanding the regulations and guidelines;
- Identifying the components
of the system life cycle;
- In-depth look at the validation deliverables;
and
- Planning, conducting and documenting the computer validation
audit.
Good Clinical Practice: Understanding the Basics
Session Chairs: Anthony S. Brewer MBA, RQAP-GLP, Ethicon Endo-Surgery,
Inc. Michele P. Weitz RQAP-GCP, Medivation, Inc.
Speakers:
Jeanine Barsotti, Amgen, Inc.
Anthony S. Brewer MBA, RQAP-GLP, Ethicon Endo-Surgery, Inc.
Paula
Hamilton, Takeda Global Research & Development Center
Inc.
Jacqueline M. Hevy RQAP-GCP, Amgen, Inc.
Lisa R. Knox, Exelixis, Inc.
Cheryl M. McCarthy CQA, Eliassen eClinical Solutions
Cathy Stevens-Hernandez, Genentech
Jean Toth-Allen PhD, FDA/OC/OSHC/GCPP
Michele P. Weitz RQAP-GCP, Medivation, Inc.
Target Audience:
This session is targeted to auditors, monitors, coordinators and
investigators with less than 2 years of clinical research experience.
Course Objectives:
Upon course completion, the attendee shall have a solid foundational
knowledge of Good Clinical Practices.
Course Description:
This session will provide auditors, monitors, coordinators and investigators
with a solid foundational knowledge of Good Clinical Practices. Topics
to be covered include: principles of GCP, adverse events, auditing,
the informed consent process, the IRB’s role, essential documents,
investigational product accountability and source data.
Biotechnology: Methodology and Auditing
Session Chair: Joan M. Rejda-Heath PhD, RQAP-GLP, Monsanto Company
Speakers:
Joan M. Rejda-Heath PhD, RQAP-GLP, Monsanto Company
Niki K. Scanlon, Monsanto Company
Mary T. Stepheson RQAP-GLP, Monsanto Company
Target Audience:
Quality Assurance auditors with at least one year of experience and a basic
understanding of the structure of DNA, RNA, and protein.
Course Objectives:
The attendee shall be able to:
- Understand the methodology used to create genetically-modified organisms
- Understand
the methods used to characterize DNA, RNA, and protein
- Identify the
critical steps in characterization methods
- Understand how to review
the different forms of data produced during characterization
Course Description:
Recombinant DNA technology is being used daily to develop new products
(e.g., pharmaceuticals, crops that can protect themselves from insect
attack). Biotechnology is the rapidly expanding area of science that allows
these developments. Topics to be discussed in this course include:
- Basic overview of biotechnology
- Methods used in the production and
characterization of biotechnology products
- Practical guidance for
inspecting the analyses using the methods and auditing the data
Basic Veterinary Good Clinical Practice (vGCP) and Best Monitoring Practices
for the Animal Health Professional
Session Chair: Mary E. Puetz, Hematech LLC
Speakers:
Deborah Eyer Garvin RQAP-GLP, WCQTI/Pacific Rim Consulting, Inc.
Celeste M. Gonzalez, Novartis Animal Health
Barbara A. Stephenson RQAP-GLP, Pfizer Animal Health
Vernon D. Toelle PhD, USFDA/CVM/OSC/DC/BIMO and Admin. Actions
Team
Target Audience:
This entry to mid-level course is for persons working in the regulated
animal health pharmaceuticals and biologicals industry who are auditors
or monitors.
Course Objectives:
- The attendee will understand the vGCPs and applicable Federal Regulations
as they apply to regulated animal health product studies.
- The attendee
will understand what is required to perform competent monitoring
of veterinary clinical studies.
- The attendee will understand the
role of the Sponsor and their part in that role.
- The attendee will
gain an understanding of the interrelationship between federal regulations,
guidance documents, and the vGCPs.
Course Description:
This course will provide the attendee with a comprehensive overview
of the Veterinary Good Clinical Practices (VICH GL9) and applicable
federal
regulations and guidances. The attendee will also receive approximately
4 hours of practical study monitoring instruction using a highly interactive
form of instruction.
Click here for the preliminary meeting schedule
|
