Products/Publications

Products/Publications

Videos and Video-Based Training Materials
Mini-regulation Handbooks
Medical Device Quality System Manual
Training Programs
Posters

Videos and Video-Based Training Materials

10 Principles of GMP--An Orientation Video (available in DVD format)

US Version

GMP: Why Do We Need It? - Video Tape and Guide

Mini-Regulations Handbooks

Mini-Regulation Handbooks for the following topics.

GMP requirements for

	Pharmaceuticals (21 CFR Parts 210 and 211)
	Medical Devices (21 CFR Part 820)
	Blood (21 CFR Part 606)
	Food(21 CFR Part 110)

Electronic Signature Requirements (21 CFR Part 11)

Q7A GMP Guidance For API's.

Medical Device Quality Systems Manual

This manual is FDA’s interpretive guide to the new Quality System Regulation. It covers aspects of manufacturing including the new design control requirements and it contains model procedures and sample forms. This is a must-have for every medical device manufacturing plant!

Training Programs

They Trust Us - Medical Device Industry
Doing Our Best - Pharmaceutical Industry

Posters

GMP Series

State of Control	Ten Principles	Troubleshooter
Putting the Good	Make It For Yourself	Performance and Compliance
GMP Series Set of 6 Posters	Purchase these posters.

Quality Series

Quality Time After Time	Take Pride	Our Personal Responsibility
Quality Checklist	Qualification and Calibration	Procedures and Test Methods
Quality Series Set of 6 Posters	Purchase These Posters

Procedures Series

You and Written Procedures	Stop	Step By Step
Rules	Stop Get Help	SOP's
Procedures Series Set of 6 Posters	Purchase These Posters

Records Series

Accurate Record Keeping	Pride In Good Record Keeping	GMP Record
Don't Forget	Write It Down	Proof of Product Quality
Records Series Set of 6 Posters	Purchase These Posters