Location: San Diego, CA
Dates: FEB 23rd – 24th, 2015
Speaker: Betty Lane, Medical Device
Betty Lane, has over 30 years’ experience in Medical Device
quality assurance and regulatory affairs. She is the founder and President of
Be Quality Associates, LLC, a consulting company helping small and medium sized
medical device and diagnostic companies implement and improve their quality
systems for both FDA and ISO 13485 compliance band business when they became
FDA and industry requirements. Her are areas of expertise include training,
auditing, supplier management, design controls including risk management,
software validation and general safety.
Betty’s training experience includes over 25 years of training on all areas ISO
13485 and FDA cGMP, in companies where she worked as manager or director, and
for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in
medical quality and regulatory affairs as an Adjunct at Northeastern
University, Boston, MA. Betty is active in her local section of the American
Society for Quality and is also a member of the RAPS, Association for the
Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers
and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic
Institute, and an MBA from Northeastern University.
Course Description:
Supplier selection and management is
one of the critical issues for medical device manufacturers. Suppliers provide
materials and services to the device manufacturer, which means that they can be
critical to performance and delivery of your device. Neither the FDA nor your
notified body regulates your suppliers (with a few exceptions). They expect you
to have an effective process to ensure your suppliers perform in the regulatory
environment.
How well do you understand the requirements for supplier management?
Could you pass a regulatory audit or inspection without any issues?
This course delivers the tools, templates, and methods to help participants
implement an effective and efficient supplier management program.
This two-day hands-on course provides a clear understanding of the underlying
principles of supplier management. The course uses exercises to solidify
understanding. In addition, the course uses FDA Warning Letters to illustrate
the points and help you learn from others. As part of the practical
implementation, the course includes receiving acceptance activities, outsourced
processes, process validation at the suppliers’ location, supplier auditing
techniques, and supplier issues in management review.
The course uses the Global Harmonization Task Force (GHTF) framework, but
expands it to cover other issues and techniques important in effective
implementation.
Reasons to attend:
Upon course completion, participants will:
- Understand FDA QSR and ISO 13485 requirements for
supplier management
- Creating a Risk-based Multi-tier supplier
classification system
- Understand when suppliers have to register and list
with the FDA
- Defining and using supplier Metrics
- Explain the link between design control and purchasing
data
- Develop an risk-based supplier management process
- Incorporating supplier regulatory and safety risk
- Incorporating supplier business risk
- Create supplier measurement and monitoring systems
- Understand the how to develop and implement supplier
controls
- Create a risk based Value-added system for supplier
audits
- How to prepare yourself and your contract manufacturer
for unannounced audits from your Notified body
- Creating acceptance criteria and understand how that
fits into your supplier control process
Things you will receive as part of
this seminar:
- Two guidance documents mentioned
- Example Approved Supplier list
- 2 examples or Supplier QA Agreements
Target Audience:
Anyone who need to expand their knowledge of supplier management requirements
or best practices for supplier management:
- QA Specialists
- Internal auditors
- Consultants
- Quality engineers
- Quality Managers
- Supplier engineers
- Supplier auditors
- Product development personnel
- Production Managers
- Production Engineers
- Regulatory Affairs Managers
- Regulatory Affairs specialists
- Compliance Managers
- Human Resources Managers
- Executive Management
AGENDA:
Day 1: EU Directives 8:30am – 9:00am - Registrations
9:00 AM – 10:30 AM:
Medical Device Regulations in US and Canada
10:30 AM – 10:40 AM: Break
10:40 AM – 12:00 Noon
- Medical Device Regulations in
EU
- DIRECTIVE 93/42/EEC
Concerning Medical Devices (MDD)
- DIRECTIVE 90/385/EEC
Concerning Active Implantable Medical Devices (AIMDD)
- DIRECTIVE 98/79/EC Concerning
in vitro diagnostic medical devices (IVDD)
- DIRECTIVE 2007/47/EC Amending
MDD and AIMDD
12:00 Noon – 1:00 PM: Lunch
1:00 PM – 2:30 PM
Medical Device Regulations in Argentina, Australia, Brazil, India, and Japan
2:30 PM – 2:40 PM: Break
2:40 PM – 4:00 PM
Medical Device Regulations in Mexico, Russia, South Korea, and Taiwan
|
Day 2: GLP Workshop 8:30 AM – 10:00 AM
- ISO 13485
- ISO 14971
- ISO 14155
- GHTF documents
10:00 AM – 10:10 AM: Break
10:10 AM – 12:00 Noon
- MEDDEV guidance documents
- Clinical investigation
|
Please
Click hear for Agenda.
To
Enroll for This Program today please click hear
Thank
you & Regards,
Kevin
Roberts,
Training
Manager,
kevin.roberts@complianzworld.com
Call
us at this Toll Free number: +1-866-978-0800
http://www.complianzworld.com