Seminar on Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC) training seminars presented by Global Compliance Panel register now on FindaSeminar.com

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

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By:

Global Compliance Panel   

For:

Regulatory Affairs VP, Director and Managers, Regulatory Affairs Associates and Specialists, Compliance Officers, Research & Development Product Managers, Quality Assurance and Quality Engineers

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


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

Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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 Notification - 510(k) and Premarket Approval (PMA)

Regulations for Production & Process Control

Readiness for FDA Facility Inspection

Why should you attend?

The complex network of multilayer laws, regulations and regulatory requirements create confusion and misinterpretation that leads the device manufacturer into Non-compliance state. Non-compliance to applicable laws and regulations results into severe penalties or regulatory actions form U.S. FDA that could damage image and position of the company. To avoid such undesired circumstances, it is important to see a big picture of TPLC and all applicable U.S. FDA laws and regulation at each phase of their own product life cycle.

Areas Covered in the Session:

 

An Overview of U.S. FDA Regulation for Medical Devices

Quality System Regulation 21 CFR 820: Current GMP for Medical devices

Premarket Notification - 510(k) and Premarket Approval (PMA)

Post Market Reporting Requirements

FDA Facility Inspection

Agenda:

Day 1 Schedule:

Lecture 1: Total Product Life Cycle and Your Medical Device

Understand various definitions of Total Product Life Cycle

Importance for define TPLC for your own medical device

Practice Exercise: Define TPLC of your own medical device

Building Regulatory Strategy considering TPLC

Lecture 2: An Overview of U.S. FDA Medical Device Regulation - Part 1

Lecture 3: An Overview of U.S. FDA Medical Device Regulation - Part 2

Lecture 4: Regulations for Design and Product Development

Research & Development

Design Development and Control

Prototype Product Development

Design Verification

Design Validation

Design Transfer to Manufacturing/Production

Helpful Hints and Suggestions

Day 2 Schedule:

Lecture 1: Premarket Notification - 510(k) and Premarket Approval (PMA)

Determine Class of your Medical Device for Regulatory Controls

Exemption form Premarket and QS Regulation requirements

Premarket Notification - 510(k)

Premarket Approval - PMA

Investigational Device Exemption - IDE for clinical studies

Preparation of Premarket Submissions

Helpful Hints and Suggestions

Lecture 2: Regulations for Production & Process Control - Part 1

Purchasing & Supplier Controls

Document Control

Device Identification and Traceability

Acceptance & Nonconforming Product Control

Labeling & Packaging Control

Helpful Hints and Suggestions

Lecture 3: Regulations for Production & Process Control - Part 2

Corrective Action and Preventive Action (CAPA)

Records - Device History Record, Device Master Record, QS Record

Complaint Files including Medical device Reporting (MDR)

Post Market Reporting Responsibilities

Helpful Hints and Suggestions

Lecture 4: Readiness for FDA Facility Inspection

FDA Authority & Practices

FDA Compliance Program Policy, Strategies and Approach

Prepare and Stay Focused during Inspection

Responding to FDA Form 483 Observations

Responding to Warning Letter

Planning and Managing Remediation Project & Activities

Additional Regulatory Actions

Speaker:

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 doesn't" form his own experience. He has presented numbers of technical papers at conferences and conducted plentiful training seminars in various countries. He is a Fellow of world's renowned Regulatory Affairs Professional Society (RAPS) and holds professional recognition as a Regulatory Affairs Certified (RAC) form RAPS. He also holds professional certification as Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) form American Society for Quality (ASQ). His educational background includes BS degree in Mechanical Engineering and BS degree in Chemistry. He founded MD Reg Consulting, LLC based in New Jersey, USA to serve medical device industry clients in all aspects of global regulatory affairs and specific to their needs.

Price: $1,295.00 (Seminar fee for One Delegate) Register now and save $200. Until May 10, Early Bird Price: $1,295.00 from May 11 to June 14, Regular Price: $1,495.00

Seminar Summary:

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. (see full course description)

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