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Applying U.S. FDA Laws and Regulations To Each Phase of Total Product Life Cycle (TPLC)

This document advertises a 2-day in-person seminar on applying U.S. FDA laws and regulations to the total product life cycle of medical devices. The seminar will be held on February 11-12, 2016 in Philadelphia and taught by Subhash Patel, an expert in FDA regulatory affairs with over 30 years of experience. Attendees will learn about regulations for various stages of the product life cycle including design, development, production, inspections and pre-market submissions. The agenda covers topics such as device classifications, quality systems, design controls and preparing for FDA inspections. Participants receive a certificate, interactive sessions and access to the expert after the event. Discounts are available for multiple attendees.

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46 views3 pages

Applying U.S. FDA Laws and Regulations To Each Phase of Total Product Life Cycle (TPLC)

This document advertises a 2-day in-person seminar on applying U.S. FDA laws and regulations to the total product life cycle of medical devices. The seminar will be held on February 11-12, 2016 in Philadelphia and taught by Subhash Patel, an expert in FDA regulatory affairs with over 30 years of experience. Attendees will learn about regulations for various stages of the product life cycle including design, development, production, inspections and pre-market submissions. The agenda covers topics such as device classifications, quality systems, design controls and preparing for FDA inspections. Participants receive a certificate, interactive sessions and access to the expert after the event. Discounts are available for multiple attendees.

Uploaded by

api-252950791
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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

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