"Hittin' the High Note on Quality:
Capitalizing on the Benefits of QA throughout an Organization."
TRAINING DESCRIPTIONS
Preconference and Postconference Training will be offered in conjunction
with the 2007 Conference.
Most training courses have limited registration capacities. SQA
will indicate on this page if a course becomes full. If you register for
a course after it has filled, you will be notified that it is full and given
the option to either be added to the waiting list, choose a difference course,
or withdraw your registration for the course. If you choose to be added
to the waiting list, you will not be charged for the course unless a spot
opens up for you and you confirm that you still wish to be registered.
Please visit the Registration
page to
register for Training.
PRECONFERENCE TRAINING
Sunday, 29 April 2007
Each session is 8:00 am - 5:00 pm (Lunch break 12:00 - 1:00 pm).
Basic Training: Good Laboratory Practice
Session Chairs: James J. Carignan RQAP-GLP
Kimberly S. Frazier, Pfizer, Inc.
This full day basic training course offers a refreshing approach to the Good
Laboratory Practice (GLP) FDA and EPA (FIFRA and TSCA) regulations and standards.
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. The training course would be
valuable to anyone with less than 2 years of GLP experience as well as study
directors, monitors, coordinators, QA professionals, scientists, technical
staff, supervisors and management and anyone involved with GLP studies. The
course could also serve as a refresher for more experienced study personnel.
Introduction to Principles
of Computer Validation for the QA Professional
Session Chair: Joseph A. Franchetti, JAF Consulting, Inc.
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, Ethicon Endo-Surgery, Inc.
Michele
P. Weitz, Novartis Pharmaceuticals Corporation
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
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 methods and auditing the data
Introduction to Effective Technical Communication Tools for
the QA Profession
Session Chair: Catherine M. Bens, USDA
PART 1: Effective Technical Writing for Publications:
Writing a technical
article for a leading professional journal, or just your in-house newsletter,
can be a daunting task. As a Quality Assurance (QA) professional, you may
never have been encouraged to write technical articles about QA or related
fields. However, good written communication skills can not only enhance your
ability to communicate among technical staff members, they can also serve
to enhance your professional standing. This part of the course is intended
as an active, hands-on workshop for QA professionals who are interested in
developing their understanding the process of writing, submitting, editing
and publishing an article in a professional journal. Participation by Wiley
managing staff, and the QA Journal editorial staff, will provide a hands-on
understanding of the publication and editorial processes.
PART 2: Effective Writing for Inspection/Audit Reports:
Writing Inspection Reports is a critical function of the Quality Assurance
professional. Effective reports can be used to educate personnel, improve
research quality and regulatory compliance, improve organizational effectiveness
and image, and lead to better rapport between the QA unit and Research staff.
Poorly written reports can lead to loss of quality and regulatory compliance,
confusion and the development of antagonistic relationships. This session
will review the essential regulatory requirements of the QA Inspection report.
It will present a variety of styles and formats as well as review common
misconceptions associated with inspection reports and various report styles.
Examples will be reviewed and discussed in terms of strengths and weaknesses.
PART 3: Effective Presentation Skills:
Whether you are presenting technical material to a small group of colleagues
at your workplace or to a large unfamiliar audience at an SQA annual meeting,
the effective use of technical teaching tools can make the difference in
getting your message across or not. This class will explore technical teaching
tools and methods that will increase instruction effectiveness, accommodate
differences in audience skill and knowledge levels and assist in verifying
retention of information. Material covered will include the effective use
of tools such as overheads, flip charts, white boards and PowerPoint slides
and methods such audience participation, analogies, mnemonics and visual
graphics to help illustrate and explain technical material for long term
retention. Creating interactive handouts and instructor notes will also
be discussed.
Monday, 30 April 2007
Each session is 8:00 am - 5:00 pm (Lunch break 12:00 - 1:00 pm).
Advanced Training: Good Laboratory Practice
THIS SESSION IS NOW FULL. You
may still register for the Friday, 4 May 2007 session of this course.
Session Chairs: Ninette Propst Burns RQAP-GLP, Southern Research
Institute
Nancy
Gongliewski, GlaxoSmithKline
You know the GLPs and you have learned how to audit. What’s the next
level on the learning curve? Dealing with agency inspections, 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 are some of the topics we will discuss in this advanced GLP
training session. 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.
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.
Advanced Training: Good Clinical Practice
THIS SESSION IS NOW FULL.
Session Chairs: Pamela K. Barry, Cephalon, Inc.
Eileen
Donovan RN, Cephalon, Inc.
This interactive session will cover a variety of topics relevant to the experienced
GCP QA Professional. Topics will include GCP in Pediatric trials and auditing
in Latin America, IRB topics, Pre FDA inspection preparation, Fraud and Misconduct
and Auditing skills. Participants will be encouraged to share experience and
ideas with their peers, with the goal of enhancing current knowledge and developing
new approaches. Active participation of the attendees will be a key to the
success of this session which will be led by facilitators with significant
expertise in their area of discussion.
Compliance Requirements
for Equipment & Instrumentation in GLP Studies
THIS SESSION IS NOW FULL.
Session Chair: LaDonna J. Camrud RQAP-GLP, American Preclinical Services
This workshop will provide guidance and practical tools to the quality assurance
professional for evaluating compliance with FDA GLP requirements for equipment
used in the generation, measurement, and assessment of nonclinical laboratory
data in medical device studies. This session will discuss basic validation
principles, provide guidance in defining facility and study specific equipment
requirements, cover the basics of equipment documentation, and offer tips
and tools for assessing equipment for compliance. This session is targeted
at the basic QA level and focuses on equipment used in the laboratory beyond
basic analytical laboratory equipment and automated computerized systems.
Study Director Training
Session Chair: Celeste A. Rose RQAP-GLP, RoseTECH Consulting, Inc.
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. This
workshop is designed for persons serving in the role of Study Director, as
well as managers or QA professionals, who wish to gain an increased understanding
of the Study Director role and GLP responsibilities and learn how to effectively
and compliantly execute quality GLP studies.
POSTCONFERENCE TRAINING
New for 2007!
Friday, 4 May 2007
Each session is 8:00 am - 5:00 pm (Lunch break 12:00 - 1:00 pm)
unless otherwise stated.
Basic Training: Good Laboratory Practice
Session Chairs: James J. Carignan RQAP-GLP
Kimberly
S. Frazier, Pfizer, Inc.
This full day basic training course offers a refreshing approach to the Good
Laboratory Practice (GLP) FDA and EPA (FIFRA and TSCA) regulations and standards.
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. The training course would be
valuable to anyone with less than 2 years of GLP experience as well as study
directors, monitors, coordinators, QA professionals, scientists, technical
staff, supervisors and management and anyone involved with GLP studies. The
course could also serve as a refresher for more experienced study personnel.
Advanced Training: Good Laboratory
Practice
Session Chairs: Ninette Propst Burns RQAP-GLP, Southern Research
Institute
Nancy
Gongliewski, GlaxoSmithKline
You know the GLPs and you have learned how to audit. What’s the next
level on the learning curve? Dealing with agency inspections, 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 are some of the topics we will discuss in this advanced GLP
training session. This session is intended for QA professionals with 2 years
or more GLP experience.
Assuring GLP Compliant Non-Clinical Medical Device Studies
Session Chair: Cynthia R. Ivey RQAP-GLP, WL Gore & Associates, Inc.
This session will focus on the requirements and circumstances affecting non-clinical
medical device studies including combination products and multi-site studies.
Topics will include protocol development, final report preparation and study
closure, and tips for auditing non-clinical medical device studies, with discussion
of the applicable regulations, recent 483 findings, industry standards, and
helpful hints for assuring compliance in medical device studies.
BioAnalytical
Training (half-day am) 8:00 am - 12:00 pm
Session Chairs: Kathryn L. Fetzer, HLS
Maria
T. Radino, HLS
The SQA BioAnalytical Specialty Section will be presenting a half-day training
session covering a variety of interesting topics for the QA professional.
The current schedule of topics includes fundamentals of pharmacokinetics,
biomarkers, validation of bioanalytical test methods and auditing of bioanalytical
data. Whether bioanalysis is your expertise or a new curiosity, we encourage
you to join us.
Value-Added Auditing (half-day pm) 1:00 pm - 5:00 pm
Session Chair: Deborah Smith RN, CCRC, Pharmceutical Services Corporation
Performing or hosting an audit can be time consuming and, often, not beneficial.
This course explores best practices for auditors and auditees, and enables
the participants to enhance the value of their audit experiences.
Manager’s Guide
to Process Improvement
Session Chair: Patricia Rossman MT (ASCP) SBB, CSQE, Pharmceutical Services Corporation
Lack of processes, or poorly-defined processes, can be costly to an organization
and, in life sciences can be dangerous to patients and workers. This course
will give managers and others techniques and tools to define their organizations
processes, analyze problems and areas of inefficiency, design and implement
new, improved processes, and measure improvements.
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