Process Validation Requirements and Industry Practice
This 2½ day program provides
regulatory affairs experts, quality systems professionals, manufacturing
engineers, and process development engineers with the knowledge
and skills needed to comply with the process validation requirements
of the FDA's Quality System regulation while offering information
on how to implement an effective validation program.
Objective
Upon completion of the course, participants
will be able to apply the principles of process validation to their
operations and know how to choose relevant statistical tools and
techniques. Participants will also come away with an understanding
of the final process validation guidance issued by the Global Harmonization
Task Force in 2004.
Program
At-A-Glance
The course consists of 2½ days
of intensive coverage and practical application of the elements
of process validation, including:
DAY
ONE
8:00
AM-5:00 PM |
Introduction and Overview to Process Validation |
| Quality System Regulatory Requirements for Process Validation |
| Elements of Process Validation |
| Process Validation and Design Control |
| Equipment Installation Qualification (IQ) |
DAY
TWO
8:00
AM-5:00 PM |
Process
Operation Qualification (OQ) |
| Statistical Methods and Tools for Process
Validation |
| Performance
Qualification (PQ) |
| Software Validation |
DAY
THREE
8:00
AM-12:00 PM |
FDA Inspectional Approach |
| Process
Monitoring, Control and Documentation |
| Retrospective Validation |
| Revalidation |
Who Should Attend?
Designed for professionals from
medical device manufacturers, consulting
businesses, European notified bodies and
conformity assessment bodies, FDA, and
other organizations or companies that
require information on FDA’s Quality System
regulation. To maximize the peer learning
opportunity, AAMI recommends this
course for those who already have a basic
understanding of the regulation and have
direct work experience.
Dates
& Hotels
| DATES |
LOCATION |
PHONE & RATES |
| November 3-5, 2010 |
Hotel del Coronado
1500 Orange Avenue
Coronado, CA 92118
Website |
800-468-3533 / 619-435-6611
$199 single/double
rate through October 1, 2010 |
| NOTE: Reservation request should be made as soon as possible, but no later than the "rate through" date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. |
|
Faculty
Course faculty are drawn from an experienced
group of quality system professionals. All course 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
Fees include the textbook, The Quality System Compendium; participant notebook of course materials 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 |
2010
FEES |
| AAMI
Corporate & Institutional Member |
$1685 |
| AAMI
Individual Member |
$1785 |
| Nonmember |
$2085 |
| Government
Employee |
$585 |
|
|
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