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. Plus, participants will come away with an understanding of the process validation guidance issued by the Global Harmonization Task Force in 2004.

Format
This program provides intensive coverage of the elements of process validation. The highly interactive format includes a variety of situational analyses that provides you with the opportunity to apply new information to actual process validation scenarios. Industry "best practices" are presented to demonstrate examples for compliance strategies. In addition, participants will work through a series of case studies that illustrate the various aspects of a validation program.

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 QS 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 Operational 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 Statistics for Setting Acceptance Criteria

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 October 27-29, 2008 Arizona Grand Resort 8000 S. Arizona Grant Resort Parkway Phoenix, AZ 85044 Website 877-800-4888 / 602-438-9000 $199 single/double rate through Sep 26, 2008 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. * Due to the number of events that AAMI is holding at the Westin Arlington Gateway in 2008, it is necessary to specify which course you are attending when making your room reservation.

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.

Course Materials
Participants will receive The Quality System Compendium (the textbook from AAMI’s comprehensive course, Quality System Requirements and Industry Practice); pertinent FDA documents; additional references; and a participant’s guide for easy note-taking.

Registration Fees
Fee includes course materials, continental breakfast and refreshment breaks for three days; and lunch for first two days of the course.

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