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. In 2006, FDA brought the course in-house to train Office of Compliance employees.
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. In 2006, FDA brought this AAMI course in-house to train Office of Compliance employees.
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 |
| FDA Inspectional Approach |
DAY
THREE
8:00
AM-12:00 PM |
Process
Monitoring, Control and Documentation |
| Retrospective Validation |
| Revalidation |
|
Who Should Attend?
Instruction is targeted to professionals
directly involved in meeting FDA's Quality System requirements such
as those in regulatory affairs, quality assurance, process development,
or manufacturing. To maximize the peer learning opportunity, this
course is recommended for those who already have a basic understanding
of the Quality System regulation, including direct work experience.
Dates
& Hotels
| DATES |
LOCATION |
PHONE & RATES |
| November 2-4, 2009 |
The Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
Website |
888-627-7076
/ 703-717-6200
$209 single/double
rate through Oct 5, 2009 |
| 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, 2nd ed.; 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.
| REGISTRATION
TYPE |
2009
FEES |
| AAMI
Corporate & Institutional Member |
$1685 |
| AAMI
Individual Member |
$1785 |
| Nonmember |
$2085 |
| Government
Employee |
$585 |
|
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| MEMBERSHIP
TYPE |
2009
FEES |
| U.S. Individual Membership Rates |
$205 |
| Non-U.S. Individual Membership Rates |
$265 |
|
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