When - Mornings of

Monday, October 25, 2021 at 8:00 AM CT
-to-
Friday, October 29, 2021 at 12:00 PM CT

Where

This is an online event.

Contact

Tom Badstubner
AsteRisk, LLC
508-883-0927
tom@asteriskllc.com

2021 GAWDA Professional Compliance Webinar - Audit Excellence

Mornings of the week of October 25 - 29, 2021

Come join us to get the latest information to do well on a DOT, OSHA or FDA Food/Drug Audit.

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
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
Automated recordkeeping in compliance with 21 CFR Part 11 and Data Integrity

See note below about an optional special presentation on Monday after the FDA presentations (noon).

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/DHS Audit Excellence

What is on the Inspection Agenda
Most requested records for inspection
How to respond to an OSHA letter
OSHA's COVID-19 Inspection Process
Top OSHA violations
Overview of DHS requirements for the Gases and Welding supply industry

Note: Special 1-hour Open Q&A Session available for Cylinder Fill Plant Efficiency, Productivity and Compliance concerns hosted by Weldcoa on Monday at noon:

Whether it is fire code concerns, things to consider before making large upgrades at your facility, cryo pump trouble-shooting or more, Don Renner, Weldcoa's top Engineering Sales Manager, is here to help. Don has 45+ years of experience with cylinder fill plant and spec gas lab facility design, installs and start-ups. He has one of the most outstanding reputations in our industry for his honesty and creditability. He will offer his technical knowledge and lessons learned to support to GAWDA Members with their fill plant questions at hand.