Global
CompliancePanel
Knowledge, a Way Forward
2-day In-person Seminar:
Applying U.S. FDA Laws and Regulations to Each Phase
of Total Product Life Cycle (TPLC)
Price
Philadelphia, PA
Price:
February 11th & 12th, 2016
8:30 AM to 5:00 PM
Subhash R Patel
Subhash Patel is an accomplished Regulatory Affairs
Professional offering 30 plus year of experience in authoring, preparing
and submitting more than 150 successful premarket submissions to
U.S. FDA. He brings his expert knowledge and hands-on experience in
developing a robust premarket submission that secures clearance or
approval from U.S. FDA. He offers valuable tips and suggestions on
what works and what doesnt form his own experience. He has
presented numbers of technical papers at conferences and conducted
plentiful training seminars in various countries.
Overview:
This workshop style training course is supported by comprehensive
knowledge of U.S. FDA laws and regulations and 30 year of extensive
experience working within in the U.S. FDA regulated industries. In these 2
days, the following essential topics will be covered:
Total Product Life Cycle and Your Medical Device
An Overview of U.S. FDA Medical Device Regulation
Regulations for Design and Product Development
Premarket Notication 510(k) and Premarket Approval (PMA)
Regulations for Production & Process Control
Readiness for FDA Facility Inspection
$1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
2-day In-person Seminar:
Global
CompliancePanel
Applying U.S. FDA Laws and Regulations to Each Phase
of Total Product Life Cycle (TPLC)
AGENDA:
Day One
Day Two
Lecture 1: Total Product Life Cycle and Your Medical Device
Lecture 1: Premarket Notication - 510(k) and Premarket
Approval (PMA)
Understand various denitions of Total Product
Determine Class of your Medical Device for
Life Cycle
Regulatory Controls
Exemption form Premarket and QS
Importance for dene TPLC for your own
medical device
Regulation requirements
Premarket Notication - 510(k)
Premarket Approval - PMA
Practice Exercise: Dene TPLC of your own
medical device
Investigational Device Exemption - IDE for
clinical studies
Preparation of Premarket Submissions
Building Regulatory Strategy considering TPLC
Helpful Hints and Suggestions
Lecture 2: Regulations for Production & Process Control
Lecture 2: An Overview of U.S. FDA Medical Device
Regulation - Part 1
- Part 1
Purchasing & Supplier Controls
Document Control
Lecture 3: An Overview of U.S. FDA Medical Device
Regulation - Part 2
Device Identication and Traceability
Acceptance & Nonconforming Product Control
Labeling & Packaging Control
Helpful Hints and Suggestions
Lecture 4: Regulations for Design and Product Development
Research & Development
Lecture 3: Regulations for Production & Process Control
- Part 2
Corrective Action and Preventive Action
(CAPA)
Design Development and Control
Records - Device History Record, Device
Master Record, QS Record
Prototype Product Development
Complaint Files including Medical device
Reporting (MDR)
Design Verication
Post Market Reporting Responsibilities
Helpful Hints and Suggestions
Design Validation
Design Transfer to Manufacturing/Production
Lecture 4: Readiness for FDA Facility Inspection
FDA Authority & Practices
FDA Compliance Program Policy, Strategies
and Approach
Prepare and Stay Focused during Inspection
Helpful Hints and Suggestions
Responding to FDA Form 483 Observations
Responding to Warning Letter
Planning and Managing Remediation Project
& Activities
Additional Regulatory Actions
2-day In-person Seminar:
Global
CompliancePanel
Applying U.S. FDA Laws and Regulations to Each Phase
of Total Product Life Cycle (TPLC)
What You will get
Group Participation
10%
2 Attendees to get offer
20%
3 to 6 Attendees to get offer
25%
30%
Learning Objectives
Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
7 to 10 Attendees to get offer
10+ Attendees to get offer
Payment Option
based trainings.
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
Special price on future consulting or expertise
services.
Check: Kindly make the check payable to
NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
GlobalCompliancePanel.
Fremont, CA 94539, USA
PO: Please drop an email to
[email protected] or call the
Special price on future seminars by
Seminar Kit includes presentation handout,
our toll free +1-800-447-9407 for the invoice and
ID card, brochure, trainings catalog, notepad
you may fax the PO to 302 288 6884
and pen.
Wire Transfer: Please drop an email to
[email protected] or call our
toll free +1-800-447-9407 for the wire transfer
Networking with industry's top notch professionals
information
Contact Information: Event Coordinator
161 Mission Falls Lane, Suite 216,
Kindly get in touch with us for any help or
information.
Fremont, CA 94539, USA
Look forward to meeting you at the seminar
NetZealous LLC, DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email:
[email protected]www.globalcompliancepanel.com
GlobalCompliancePanel
