Process Validation Requirements & Industry Practice Workshop
This 2 1/2 day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real life process validation examples.
Objectives
Upon completion of this course, participants will be able to:
- Determine which processes require validation and develop a Master Validation Plan
- Develop protocol content to ensure a successful validation
- Document the results and the resolution of deviations that occur during validation
- Plan for effective monitors and controls for the validated processes
- Determine the revalidation requirements for product and process changes
Program At-A-Glance |
|
DAY ONE - 8:00 AM-5:00 PM |
|
|
|
DAY TWO- 8:00 AM-5:00 PM |
|
|
|
DAY THREE - 8:00 AM-NOON |
|
|
Format
This 2 1/2 day program provides intensive coverage of process validation 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.
Who Should Attend?
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.
Participants who need more information to apply statistics should consider attending other AAMI courses & webinars:
- Fundamental Statistical Tools and Methods for a Quality System
- Introduction to Valid Statistical Techniques for Process Validation
- Introduction to Design of Experiments for Process Validation
Dates & Hotels
| DATES | LOCATION | PHONE & RATES |
| April 29 - May 1, 2013 | The Westin Arlington Gateway 801 North Glebe Road Arlington, VA 22203 Website |
703-717-6200 $209 single/double Rate through 3/31/2013 |
November 4-6, 2013 |
Red Rock Casino Resort Spa 11011 West Charleston Boulevard Las Vegas, NV 89135 Website |
866-767-7773 | 702-797-7777 $140 single/double Rate through 10/6/2013 |
Faculty
Workshop faculty are drawn from an experienced group of quality system professionals. All faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders, consultants, and FDA personnel helps to ensure a balanced presentation of the process validation requirements and paths to compliance.
Fees and Registration
Fee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
| REGISTRATION TYPE | FEES |
| AAMI corporate and institutional member | $1735 |
| AAMI individual member | $1835 |
| Nonmember | $2135 |
| Government employee | $635 |
| OPTIONAL ONLINE POST-TEST | FEES |
| AAMI members and government employees | $50 |
| Nonmembers | $75 |