Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices Seminar training classes conferences & workshops presented by ComplianceOnline register for training on FindaSeminar.com

Home

Add your seminars

Training Calendar Creator Seminar Venues Training Provider Directory
 

New Seminar Search:  

 

Helpful links

find similar training...
Search by state...
Customer Support


Do you need help finding the right class, date, or location or other assistance?

Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request and receive a prompt reply.

We guarantee this ComplianceOnline training seminar

We are an authorized partner of ComplianceOnline

 

Price protection. The price to attend Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices is set by the training providerThere is no added charge for our services.

We honor most training provider coupons
*.   Call  a representative to see if your discount coupon applies.


Privacy. Your personal information won't be shared with anyone but the training provider ComplianceOnline.


Security. When you register for this seminar on FindaSeminar.com your personal data and payment information is safely collected and processed using secure SSL encryption technology.

Flexibility. FindaSeminar.com offers you three ways to register for Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices seminar by ComplianceOnline.
Register online, by phone (800) 349-1935,or fax (800) 712-5569
Who should attend Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices
Quality professionals, Compliance professionals, Production supervisors, Auditors, Manufacturing engineers, Design/development engineers, Process owners, Quality engineers
Reviews
Write and read ComplianceOnline reviews and reviews about the training seminar Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices on the Seminar News Network and the Training News Network.
 

Frequently asked questions and registration options for the training seminar Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices

 
Find Training Near You
Use our clickable map to find training near you
Use Our Clickmap
 
hotel seminars meeting space directory
hotel meeting space training facilities restaurant and lodging

 
 
 

request on site training details for the Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices seminarRequest on site training

Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices  

 Email information about this seminar Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices by ComplianceOnline to yourself your manager or associatesEmail this event... View and register for other training seminars like Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices by ComplianceOnline on FindaSeminar.com See similar training.. Find and register for other training seminars by ComplianceOnline on FindaSeminar.com Other seminars from ComplianceOnline

By:

training seminars by ComplianceOnline ComplianceOnline   

For:

Quality professionals, Compliance professionals, Production supervisors, Auditors, Manufacturing engineers, Design/development engineers, Process owners, Quality engineers

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

Attendees will learn what, when, why, and how to conduct process validation in compliance with FDA and international agency regulations.  (see full course description)

 
 
 

 Seminar / Training class dates & locations

 

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search


 

 
 

print the agenda print agenda for the Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices seminar

 

Training Course Syllabus:


Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices

This two day course provides the fundamental knowledge needed to comply with the FDA´s cGMP QSR, ISO, and International Medical Device Regulators Forum (IMDRF) (formerly GHTF) requirements for process validation and offers practical advice on how to develop and implement an efficient and effective validation program.
Attendees will learn what, when, why, and how to conduct process validation in compliance with FDA and international agency regulations. Additional topics covered in the course include how to develop pragmatic protocols, maintaining satisfactory validation documentation, how to define and perform the IQ/OQ/PQ validation sequence, analysis of trending data, and evaluating the need for re-validation.

Learning Objectives:

Understand when and why validation is required
Become familiar with regulatory requirements, industry practice, and associated guidance documents relevant to process validation
Understand the consequences of not validating or doing it poorly
Define the components of a good validation strategy
Application of problem solving methods to help asses which strategy is best in various situations
Develop successful validation master plans
Define requirements for validation documentation
Write a comprehensive protocol
Common statistics for sound results
Executing the IQ/OQ/PQ validation sequence
Establish ongoing process monitoring and control requirements
Evaluate when revalidation is needed

DAY 01(8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
What is Validation?
Validation vs. Verification
Types of Validation
History and Recent Trends
Why Validate?
Economic Reasons
Consequences of Not Validating – 483 and Warning Letter Examples
Regulatory Requirements and Expectations
Quality System Regulation 21 CFR 820
Industry Guidance Documents
Global Harmonization and Expectations
Definitions and Terminology
FDA vs. GHTF
Key Term Glossary
When to Validate
Processes Requiring Validation
Validation Decision Tree
Processes NOT Requiring Validation
Validation Planning
Validation Timing
Prospective Validation
Defining Your Strategy
Establishing the Process Validation Program
Validation Trade Offs
Validation Process Flow Overview
Risk Management as a critical tool
Validation Documentation
Process Validation Master Plan (PVMP)
Protocol
Analysis Techniques
Policies and procedures

DAY 02(8:30 AM - 4:30 PM)

Validation Sequence
Installation Qualification (IQ)
Agency Definitions and Key Components
Conducting IQ
Operational Qualification (OQ)
Considerations and Key Components
Measurement and Sources of Variation
Experimental Design
Sample Sizes
Statistical Process Control
Process Capability
Performance Qualification (PQ)
Considerations
Summarizing and Reporting Data
Ongoing Process Monitoring
Revalidation
How to Handle Validation Failures
Case Studies
Validation Strategy and Planning
Specific Elements of the Protocols
Process Monitoring and Controls
Initial Monitoring
Ongoing Controls
Revalidation
When to Revalidate
Rationale for NOT revalidating
Case Studies
Validation Strategy and Planning
Specific Elements of the Protocols
Questions

Seminar Summary:

Attendees will learn what, when, why, and how to conduct process validation in compliance with FDA and international agency regulations.  (see full course description)

print this agenda print agenda for the Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices training seminar

 view dates and locations for this seminar

 

 
 
 ComplianceOnline training and seminar course catalog

Click any title to view upcoming ComplianceOnline training event dates and locations, class syllabus and other seminar details

 

     
 

 
     

 

  Also try the advanced seminar search tool

   FindaSeminar HomeComputer Training

unix training
training classes

 © 2002-2018 FindaSeminar.com™ All Rights Reserved.  Terms of Use |  Privacy Policy |  Training News Network