Building a Sustainable Validation Program from Top to Bottom

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Category FDA Compliance;

Deadline: May 18, 2016 | Date: May 18, 2016-May 19, 2016

Venue/Country: Miami, U.S.A

Updated: 2016-04-13 21:42:17 (GMT+9)

Call For Papers - CFP

While an organization has ample experience in perfecting its process validation program, it may not be able to get its arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ).

Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer.

For systems that employ software and hardware, how does the company manage the validation activities, i.e. through the software validation effort or through the equipment qualification program?

The answers to these and many more typical questions and scenarios will be detailed in this training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Learning Objectives:

This FDA validation seminar will instruct attendees on:

How to Define a Sustainable Structure of a Firm’s Validation Program

Understanding How Change Control and Other Quality Programs Feed Into the Validation Program

Analyzing Usable Protocol and Other Validation Program Document Templates

How to Define Minimal Recommended Tests and Verifications for

Equipment Qualification

Process Validation

Software Validation

Who will benefit:

This seminar will help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program. The following job titles/ positions will benefit from attending:

Internal Auditors

Regulators

Legal Department Personnel

Compliance Officers

Validation Managers

QA/QC Managers

Facilities and Engineering Department Staff

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-validation-program-iq-oq-pq-seminar-training-80147SEM-prdsm?channel=ourglocal