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Process Validation for Medical Devices: 2-day In-person Seminar  

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Quality engineers, Production engineers, Design engineers, Risk management specialists, Production managers, Production supervisors, Medical device manufacturers, Device QA/QC personnel

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Seminar Summary:

This course will help attendees understand the regulatory requirements and the statistical methods needed to perform effective process validation for medical device manufacturing. (see full course description)

 

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Training Course Syllabus:


Process Validation for Medical Devices: 2-day In-person Seminar   -  FDA Compliance Training Seminar
By: Dan O'Leary, President at Ombu Enterprises, LLC


Course Description:

Medical device manufacturers can avoid FDA Warning Letters, 483s and enforcement actions with a good understanding process validation principles. But knowing how to proceed is the toughest task as no FDA guidance document is available which talks about it.

This two day interactive seminar is designed to make you understand the regulatory requirements of both FDA QSR and ISO 13485:2003. To compensate for the missing guidance document, the course draws the “how to” answer from various other sources including the GHTF guidance, FDA’s QSIT, FDA Warning Letters, and the guidance document for ISO 13485:2003. This course will help attendees understand the regulatory requirements and the statistical methods needed to perform effective process validation for medical device manufacturing.

During this two day seminar the instructor will focus on:

  • Regulatory requirements from FDA QSR and ISO 13485:2003
  • How to use process validation for ISO 14971:2007 risk reduction
  • How to apply corrective action properly in solving problems
  • How process validation supports the production and process control requirements of QSR
  • Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) techniques and their application in process control
  • Applicable OSHA regulations, Hazard Analysis and Critical Control Point (HACCP) to ensure a robust system
  • The relationship between “validated with a high degree of assurance” and process capability indices
  • How to use design of experiments (DOE) to define the input parameter space, an essential element of Operational Qualification



Process Validation for Medical Devices Course Outline:

Day One (8:30 AM – 5:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Process Validation Concepts
When to validate a process
Contrasting process output verification and process validation
The regulatory definitions of process validation
The Requirements Framework
The FDA QSR requirements
The ISO 13485:2003 requirements
Using the guidance document on ISO 13485:2003
Using the GHTF guidance document for complete understanding
The Regulatory Approach
What the FDA Investigator looks for
Using QSIT to help ensure compliance
Warning Letters – Learning from others
Installation Qualification
Equipment placement
OSHA standards and how they impact equipment
Maintenance and calibration from FDA QSR
Maintenance and calibration from ISO 13485:2003
Developing checklists

Day Two (8:30 AM – 5:00 PM)


Statistical Methods (Part 1)
Process Capability
Acceptance Sampling
Statistical Process Control
Statistical Methods (Part 2)
Factorial Design of Experiments (DOE)
Transmission of Variation
Robust Tolerance Analysis
Operational Qualification
Exploring the parameter space with DOE
Setting control limits and action levels
Running Challenge Tests
Performance Qualification
Defining controlled conditions
Evaluating Deviations
The Process in Production
Using HACCP
Integration with Risk Management
 

Seminar Summary:

This course will help attendees understand the regulatory requirements and the statistical methods needed to perform effective process validation for medical device manufacturing. (see full course description)

print this agenda print agenda for the Process Validation for Medical Devices: 2-day In-person Seminar training seminar

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