Two Day Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle Workshop - Burlingame CA, United States - March 2-3, 2017 - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" conference to their offering.

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

Who Should Attend:

- Regulatory Affairs - VP, Director and Managers

- Regulatory Affairs - Associates and Specialists

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

For more information about this conference visit http://www.researchandmarkets.com/research/l5cc3d/applying_u_s_fda

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices