Global
CompliancePanel
Knowledge, a Way Forward
2-day In-person Seminar:
Preparing Premarket Submissions that secures U.S. FDA
Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA
Price
Boston, MA
Price:
May 5th & 6th, 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 designed based on 30 year of
regulatory affairs experience in preparing more than 150 successful U.S.
FDA submissions for major medical device companies. In these 2 days,
the following essential elements of U.S FDA premarket submissions will
be covered:
History and background of U.S FDA Laws and Regulations
Classify Your Device
Choose the Correct Premarket Submission for your device
Compile the Appropriate Information for your Premarket Submission
Author and Prepare your Premarket Submission
Submit your Premarket Submission to the FDA
Interact with FDA Staff during Review and Approval
$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
Preparing Premarket Submissions that secures U.S. FDA
Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA
AGENDA:
Day One
Day Two
Lecture 1: An overview of U.S. FDA Premarket Regulations
Lecture 1: Premarket Approval (PMA)
Applicable Laws, Regulations and
History and background of U.S FDA Laws and
Regulations
Requirements for PMA
Decide Type of PMA
Compile the Appropriate Information for PMA
How to Classify Your Device
Format and Content of your PMA
Suggestions on What to Include or Exclude
Choose the Correct Premarket Submission for
your device
into your PMA
Tips on authoring a readers friendly and
convincing PMA
Lecture 2: Premarket Notication 510(k)
Lecture 2: Premarket Approval (PMA) - continue
Critical Review of your prepared PMA for
Applicable Laws, Regulations and
Requirements for 510(k)
Decide Type of 510(k)
Compile the Appropriate Information for 510(k)
Format and Content of your 510(k)
acceptability
Determine risk and contingency plan for
potential questions form the reviewer
Points to Consider - Submit your PMA to FDA
Interact with FDA staff during review and
clearance of your PMA
Lecture 3: Investigational Device Exemption (IDE)
Applicable Laws, Regulations and
Requirements for IDE
Purpose and Use of Pre-IDE to your
Lecture 3: Premarket Notication 510(k) - continue
advantage
Compile the Appropriate Information for IDE
Suggestions on What to Include or Exclude
into your 510(k)
Format and Content of your IDE
Suggestions on What to Include or Exclude
into your IDE
Tips on authoring a reader's friendly and
convincing 510(k)
Tips on authoring a reader's friendly and
convincing IDE
Lecture 4: Post Market Requirements for Medical Devices
Critical Review of your prepared 510(k) for
acceptability
Quality System (QS) Regulation/Medical
Device Good Manufacturing Practices
Mandatory Medical Device Reporting (MDR)
Lecture 4: Premarket Notication 510(k) - continue
Recalls, Corrections and Removals
Medical Device Tracking
Determine risk and contingency plan for
potential questions form the reviewer
Points to Consider - Submit your 510(k) to FDA
Interact with FDA staff during review and
clearance of your 510(k)
Post Market Surveillance Studies (PSS)
mandated under section 522 of the Federal
Food, Drug and Cosmetic Act
Post-Approval Studies (PAS) mandated as a
condition of approval of a premarket
submission - mostly premarket approval (PMA)
application
Points to consider - Third Party Inspection by
Accredited Persons Program limited to
manufacturers who meet certain conditions
2-day In-person Seminar:
Global
CompliancePanel
Preparing Premarket Submissions that secures U.S. FDA
Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA
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
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