We have options to make sure you are in compliance with all FDA Medical Gas regulations.

AsteRisk FDA Tech Support Program

• FDA (cGMP) drug and device manual and program with updates customize to your companies specific practices
• FDA self assessments – annual, on-site
• Documentation of function specific training
• Documentation of Annual Records Review
• FDA consultation, as needed, to answer immediate questions
• Documented, annual, Current Good Manufacturing Practices (cGMP) training for quality/operations personnel
• Complimentary web-based monthly cGMP training, as well as "train the trainer" training

GAWDA Medical Gas Program

• FDA (cGMP) drug and device manual and program with updates streamlined industry specific (minimal customizations)
• FDA consultation, as needed, to answer immediate questions
• Complimentary web-based monthly cGMP training; part of GAWDA monthly Round Table discussion