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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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