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
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.
Program
At-A-Glance
DAY ONE
8:00 AM-5:00 PM |
- Establishing Process Validation
- Master Validation Plan
- Installation Qualification
- Operational Qualification – Process Characterization and Tools
|
DAY TWO
8:00 AM-5:00 PM |
- Operating Qualification
- Performance Qualification
- Implementation & Documentation
|
DAY THREE
8:00 AM-NOON |
- Monitoring & Control
- Revalidation
- Advanced Planning & Validation Strategies
|
|
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:
Dates
& Hotels
| DATES |
LOCATION |
PHONE & RATES |
| April 16-18, 2012 |
Renaissance Arlington Capital View Hotel
2800 South Potomac Avenue
Arlington, VA 22202
website
|
1-703-413-1300 $199 single/double
Reservation ID: AAMI
Rate through: 3/25/2012 |
| Oct 1-3, 2012 |
The Westin Alexandria
400 Courthouse Square
Alexandria, VA 22314
website |
1-866-837-4210
$209 single/double
Reservation ID: AAMI
rate through 9/9/2012 |
|
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.
Fee 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 |
2012
FEES |
| AAMI
corporate and institutional member |
$1735 |
| AAMI
individual member |
$1835 |
| Nonmember |
$2135 |
| Government employee |
$635 |
| OPTIONAL ONLINE POST-TEST |
2012
FEES |
| AAMI members and government employees |
$50 |
| Nonmembers |
$75 |
|
|
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