NetZealous LLC - GlobalCompliancePanel, Four Points By Sheraton San Diego Downtown 1617 1st Avenue - San Diego, California, 92101 - United States
2016-06-16
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
GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost 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
Who Will Benefit: - Regulatory Affairs - VP, Director and Managers
- Regulatory Affairs - Associates and Specialists
- Compliance Officers
- Research & Development - Product Managers
- Quality Assurance and Quality Engineers
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
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