2022 GAWDA Professional Compliance Seminar – Audit Excellence

Online Event – Mornings
Monday, February 28 – Friday, March 4

Click HERE for Seminar Information and Registration Form

Please join us for the two days of FDA drug and food gas audit preparation. In addition to audit preparation, we will discuss the CARES Act and current FDA enforcement initiatives.

Register Today!
GAWDA Members enter GAWDAMEMBER in the Promo Code for a 10% Discount!

AGENDA

Monday AM and Tuesday AM (8:00 AM – Noon CT): Tom Badstubner / Andre Marte
FDA Drug/Food/Bev Gas Audit Excellence

  • Latest FDA enforcement trends
  • CARES Act reporting
  • What to do (and NOT DO) when the inspector arrives
  • Drug and Food Gas Self-Assessment Tools
  • Food/Bev Gas Compliance Exceptions for small businesses
    – “Qualified Facility” status
    – Attestation
  • Practical HARPC and Supply-Chain Programs
  • RPVs and cylinder inversion issues (CGA G-6.3, etc.)
  • Key audit indicators (housekeeping, pest control, allergen, sanitation, calibrations, training, etc.)
  • How to respond to an difficult or unreasonable FDA inspection (CGA PS-42)
  • FDA Guidance – Delaying, Denying, Limiting, or Refusing a Drug Inspection
  • Easy to use Drug/Beverage/Food Gas GMP Training resources
  • Data Integrity
  • Optional – automated recordkeeping in compliance with 21 CFR Part 11

Wednesday AM and Thursday AM (8:00 AM – Noon CT): Mike Dodd
DOT Audit Excellence

  • Suggested DOT Filing System
  • Driver Qualification Files
  • Drug & Alcohol Testing 
  • Security Plan Updates
  • Vehicle Maintenance Files
  • DOT Clearinghouse Overview
  • Hazmat / Security Awareness / Security In-depth Training (Train-the-trainer and certified training) 
  • DOT Compliance Q&A and Discussion 

Friday (8:00 AM – Noon): Marilyn Dempsey

OSHA Audit Excellence
DHS and EPA Requirements for a Gas and Welding Supply Distributor
  • Inspection Agenda
  • Most requested records for inspection
  • Post Inspection actions
  • How to respond to an OSHA letter
  • Top OSHA violations
  • OSHA’s COVID-19 Inspection Process
  • Overview of DHS and EPA requirements for the Gases and Welding supply industry