North American Suppliers Directory Index

Institute of Validation Technology

200 Business Parkway/Suites E & F
Royal Palm Beach, FL 33411-1742
Tel: 561/790-2025
Fax: 561/790-2065

Web: http://www.ivthome.com
E-mail: info@ivthome.com

Publications:

The Journal of Validation Technology is industry's only peer reviewed Journal exclusively dedicated to providing practical approaches to conducting effective validations. The Journal of Validation Technology publishes information on the following areas including: processes, computers, equipment, cleaning, facilities, methods, and much more.

The Journal of cGMP Compliance is industry's only peer reviewed Journal exclusively dedicated to providing practical approaches for implementing compliance practice and strategy. The Journal of cGMP Compliance publishes information on the following areas including: handling OOS results, GMP training, pre-approval inspections, auditing techniques, FDA inspections, design control, failure investigations, and much more.

Technical Guides

Implementing a Quality System

This technical guide breaks down a quality system into three phases:

Quality System Regulation scope, executive planning, and quality improvement. It also includes a comprehensive checklist of questions that may be considered in a complete quality system audit.

Conducting Effective Medical Device Validations

Gain a thorough understanding of the basic concepts, techniques, and requirements necessary to meet current FDA expectations and requirements in accordance with the Quality System Regulation and your company's corporate validation policy for conducting timely, efficient, and effective medical device validations. Using case studies and pragmatic examples, learn the critical concepts and principles of validation. Topics include:

Developing the validation master plan and SOPs, when to revalidate, creating and executing IQ, OQ and PQ protocols, using quality tools and statistics, software verification and validation strategies, and much more.

Design Control Implementation Guide

Provides detailed task lists for each stage of design control, eleven SOPs, and training documents on disk and hard copy, feasibility study templates, design verification and validation templates, pre-release change control program, a comprehensive overview of design control requirements, and much more.

Protocol Template

510 (k) Submission Template

Information includes cover letter and sample submission format, indications for use form, possible abbreviated 510(k) risk analysis summary sample, and much more.

Categories this company is listed under in the North American Suppliers Directory:

• R&D, Design, and Business Services: Consulting/Training services (395 companies)