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.
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.
Register today!
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.