Browsing: FDA & Medical Gases

By Tom Badstubner, Ryan Combest, Mike Dodd, Rick Schweitzer, and Steve Guglielmo We last had the opportunity to catch up…

By Tom Badstubner, Marilyn Dempsey, Michael Dodd, Rick Schweitzer and Steve Guglielmo GAWDA consultants have been busy since the Second…

Thoughts Ahead of the SMC By Tom Badstubner, Marilyn Dempsey, Mike Dodd, Rick Schweitzer, and Steve Guglielmo The GAWDA…

How COVID-19 has impacted GAWDA members and what will need to be done as businesses reopen. By Steve Guglielmo, Tom…

How to stay in compliance with employee training By Steve Guglielmo, Marilyn Dempsey, Michael Dodd and Tom Badstubner Your employees…

Editor’s Note: This column can serve as a companion article for the Consultant’s Roundtable on page 14. Admin – CGMP…

The following is from the GAWDA December 2019 Monthly Safety Organizer. Frequently Asked Questions – Electronic Tracking of Lot Numbers…

A moderated discussion between Tom Badstubner and Michael Dodd By Tom Badstubner, Michael Dodd and Steve Guglielmo As members close…

A moderated discussion between Tom Badstubner and Michael Dodd by tom badstubner, michael dodd and steve guglielmo It can be…

by tom badstubner and michael dodd This GAWDA Safety Alert is issued to inform GAWDA members of potential cylinder damage…

The FDA and state regulations recognize the traditional distribution of typical prescription drugs: This distribution model works well for traditional…

What is the Latest FDA Thinking About Expiration Dates on Medical Gases? 21 CFR 211.137(a) clearly states that drugs must…

Successful specialty gas professionals consistently use sales techniques and systems to increase their performance. Of course, it is essential to…

Simplified Sample Procedures Available for Food Gases – Qualified Facilities The new Food Safety Modernization Act and 21 CFR 117 allow for…

By: Jack Hercik, Asterisk, LLC A recent series of advisories and safety alerts have been issued by various government agencies…

Effectively training your employees can accomplish several important goals: regulatory compliance, standardization, employee performance improvement, loss reduction and profit improvement.…

California Proposition 65 Regulatory Change Bulletin The purpose of this article is alert GAWDA members to upcoming critical changes to…