Advanced Process Validation For
Medical Device Manufacturers
Background : Due to the complexity of many medical
devices, routine end-product testing alone is insufficient to assure the
quality, safety and effectiveness of the device or its components.
With a focus on in-depth process validation methods and
statistical rigor, this four-day advanced session will explain the intent
and importance of process validation with respect to the regulations and
standards, emphasizing the connectivity between design controls, risk
management and statistical techniques. The training will also provide
participants the fundamental knowledge and tools to establish and implement
effective process validation lifecycle systems. Hands-on, interactive
exercises will highlight and reinforce the principles learned.
Objectives :
-
Understand the
intent and purpose of regulations as it applies to process validation and
production controls
-
Know how design
controls and risk management feed into process validation
-
Learn the
fundamentals of Test Method Validation and Measurement Systems Analysis
-
Learn to
identify which processes to verify and which process to validate
-
Be able to
develop a Master Validation Plan
-
Learn to
calculate basic quality metrics and determine sample sizes
-
Learn to use
statistical methods like design of experiments (DOE) to determine critical
process and raw material parameters
-
Learn the
principles of Installation Qualification (IQ), Operation Qualification (OQ)
and Performance Qualification (PQ) using protocols and reports
-
Understand the
basics of risk management and developing a Process Failure Mode and
Effects Analysis (PFMEA)
-
Identify key
outputs from process validation
-
Learn to
formulate methods for process monitoring and control
-
Understand the
concepts of statistical process control (SPC) and statistical quality
control (SQC)
-
Understand how
to maintain the validated state and the criteria for revalidation
|
Test Method Validation
Background : Test methods are one of the most critical elements in
the design, development, manufacture and release of products. They provide
the objective evidence for the safety and effectiveness of devices. It is
thus imperative that device manufacturers ensure their test methods used in
the determination of safety and effectiveness for their product are
suitable, capable and reliable for their intended use. Inadequate test
method validation can have severe regulatory and business consequences. In
the past few years, regulatory bodies have added additional focus on test
method suitability and reliability in their audits and inspections.
This two-day session will explain the intent and importance of test
method validation with respect to the regulations and standards. The
training will also provide participants the fundamental knowledge and tools
to establish and implement effective test method validation procedures and
processes. Hands-on, interactive exercises will be used to highlight the
principles learned.
Objectives :
- Understand the intent and purpose of regulations as it applies to test
methods across the product lifecycle
- Learn the basic principles of Test Method Validation to determine
suitability and capability of the test method for its intended use
- Understand the requirements for the qualification of test equipment
- Understand requirements for calibration
- Understand how to conduct a gauge repeatability and reproducibility
(Gauge R&R) for variable data and attribute data
- Learn the principles of method transfer
- Lear how to develop and complete test method protocols and reports
- Understand the validation life-cycle and changes to test methods
The Links For the Above Two Training Programs :
• Advanced Process Validation Training, May 16-19,2017, Chicago IL
http://winovia.com/advanced-process-validation/
• Test Method Validation Training, July 18-19, 2017, Chicago, IL
http://winovia.com/test-method-validation/ |