Training
Preconference and Postconference Training will be offered in conjunction
with the 2008 Conference. Click here
to Register!
Friday, 25 April 2008
Each session is 8:00 am - 5:00 pm (Lunch break 12:00 - 1:00 pm). Unless
otherwise noted.
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.
Effective Value-Added Auditing for the 21st Century
Session Chair: William R. Kracht, Bill Kracht Consulting Services
Speaker: William R. Kracht, Bill Kracht Consulting Services
Target Audience:
While probably most beneficial for beginning and intermediate auditors,
experienced / advanced auditors will gain some insights and ideas for improving
their audit skills as well. In addition, those involved in the selection
and/or training of auditors will find this course beneficial.
Course Objectives:
The attendee will be able to better understand and optimize the human
relations aspects of auditing for maximum value in the results.
The attendee will be able to better understand and use the FDA concepts
of system and process focus to optimize the effectiveness of both the audit
program and individual audits.
The attendee will be able to more effectively apply the skills and processes
of pre-audit, during-the-audit, and post-audit activities for maximum value
to the organization.
Course Description:
This highly interactive course will focus on the skills and process of
auditing, independent of the particular standard being audited. The main
objective of the course will be to enhance the participant's ability to
perform effective, objective, value-adding audits in any situation. Relevant
class exercises, mini-case studies, etc. will be used throughout the course,
including a pre-course “homework assignment.”
Principles of GMPs for the FDA Regulated Medical Industry
Session Chair: Howard T. Cooper, EQACT, Inc.
Speakers:
Raymond C. Anderson PhD, University of Arkansas for Medical Sciences
Howard T. Cooper, EQACT, Inc.
Gretchen Berry McAuliffe, EM2 Solutions, Inc.
Patrick Noland, ABC Laboratories, Inc.
David Rothkopf, MEDIcept, Inc.
Dennis Runser PhD, TMI Regulatory Compliance Consulting
Target Audience:
Quality professionals with all levels of experience will gain knowledge
of the GMP regulations that apply throughout the medical industry.
Other regulatory professionals will gain an insight into their own regulations
and how they share common principles and objectives. All attendees
will
learn how the nature of the product determines the impact of the
requirements of the regulations.”
Professionals working with combination products will particularly gain
insight for more effective management of their product’s Good Manufacturing
Practice requirements.
Course Objectives:
The attendee shall be able to:
- Understand the principles and objectives of the GMP regulations
I
- Appreciate the flexibility of the GMP regulations to satisfy the
stringent requirements of the medical products manufacturing environment
- Understand
that the GMP regulations share common objectives and principles yet
are designed with the flexibility to handle diverse product
characteristics that have very demanding requirements.
- Learn regulatory and
GMP terminology to improve understanding of GMP issues with other
regulatory professionals
- Learn quality principles that are applicable
to other regulatory disciplines outside the GMP arena
Course Description:
This course will demonstrate the principles and objectives of the GMP
regulations. It will do this by:
- Describing & Explaining Regulatory and GMP Terminology
- Providing
an overview of the principles and objectives common to all the GMP
regulations
- Discussing differences between the GMP regulations
- Providing an
overview of the following GMP regulations:
- Drug Substance (Q7A)
- Drug Product Part 210/211(Also FDA Guidance
on the Quality Systems Approach to GMP)
- FDA Guidance on Quality
Systems Approach to Pharmaceutical CGMP Regulations
- Medical Devices
(Quality System Regulation) Part 820
- Good Tissue Practices Part
1271
Understanding GxPs: Bridging the Communication Gap
Half-day Session, 8:00 am - 12:00 pm
Session Chair: Melissa Eitzen, MS, MT(ASCP), RQAP-GLP, University of Texas
Medical Branch
Speakers:
Raymond C. Anderson PhD, University of Arkansas for Medical Sciences
James A. Ault RAC, RQAP-GLP, Ricerca Biosciences LLC
Howard T. Cooper, EQACT, Inc.
Nancy J. Gongliewski, GlaxoSmithKline
Celeste M. Gonzalez, Novartis Animal Health
Eric Humes RQAP-GLP, ICON Development Solutions
Target Audience:
This course is suitable for all QA professionals. Novice auditors will
gain knowledge of the ‘big picture’ of the entire
regulated process while also learning important terminology.
Seasoned QA
professionals who specialize in one area of the GxPs will gain
an understanding
and appreciation of the differences and commonalities of their
colleagues who work in other specialty areas.
Course Objectives:
The attendee shall be able to:
- Appreciate regulatory specialty areas outside their scope
of expertise
- Understand differences in terminology used within specialty
areas
- Recognize commonalities and regulation overlaps between specialty
areas
- Understand the regulatory framework
- Identify industry trends within specialty
areas
Course Description:
The course is designed to broaden/promote a better understanding among
QA professionals in order to improve communication among SQA members,
sponsors, regulatory agencies, and CROs. The course includes an overview
of the regulatory framework followed by presentations on the GLP, human
GCP, veterinary GCP, GMP, and Good Tissue Practice (GTP) regulations.
Course presentations are designed with a common matrix so that all speakers
address regulation and auditing commonalities, differences, overlaps,
and industry trends. Course materials will include a glossary of terms.
SQA Leadership Training
Half-day Session, 8:00 am - 12:00 pm
Complimentary for SQA Members
SQA will offer a special leadership training for volunteers within SQA.
This training is complimentary for SQA members. If you currently
volunteer for SQA or would like to become more involved, make plans to
attend!
Click here for the preliminary meeting schedule
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