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Event Registration - Process Validation and Industry Requirements for a Global Market

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg
Start Date:
Tuesday, April 14, 2020
End Date:
Thursday, April 16, 2020
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
This 3 -day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation, the ISO 13485:2016 Standard and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples.

Registration Fees:

  • AAMI Members: $2340
  • Nonmembers: $2600
  • Government Employees: $935

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Establishing Process Validation Procedures
Master Validation Planning
Installation Qualification
Characterization & Study Design


DAY 2 | 8 AM-5 PM
Operational Qualification 
Performance Qualification
Execution of Validation


DAY 3 | 8 AM-5 PM
Monitoring & Control 
Revalidation
Advanced Planning & Validation Strategies 






 

 

Program Objective


FDA and AAMI faculty work together to help the learner to:

 • Determine which processes require validation and develop a Validation Master Plan
• Develop protocol content to ensure a successful validation • Document the results and the resolution of deviations that occur during validation execution
• Plan for effectively monitors and controls for their validated processes
• Determine the revalidation requirements for product and process changes
 • Planning, Protocol Development, Validation Execution, Monitoring & Control and Revalidation to meet the FDA’s expectation and industry’s best practices

 Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation post-course test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System Regulation and ISO 13485 Standard.

 

 

Target Audience

Instruction is geared to professionals involved with process validation in the medical device industry such as R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program Managers, and Process Engineers. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of the Quality System regulation and have some relevant work experience.

 

Format


This 3-day program provides intensive coverage of process validation and includes a variety of real-life examples, case studies, and exercises that cover process validation activities. These exercises provide participants with the opportunity to apply new information to actual validation scenarios. The course includes a general description of statistical methods and tools as they relate to process validation.

 

Materials

Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.

 

  • Event Location
    • Address:
      AAMI Conference Center, 901 North Glebe Road, Suit
      901 North Glebe Road, Suite 300
      Arlington, VA 22203
      UNITED STATES


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