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Live Webinar
How to Prepare for an OSHA Audit
An OSHA inspection provides a view into your organization’s safety culture. This training will share a step-by-step guide on how to strategically prepare for a safety audit before it happens, which includes newly defined rules that employers need to know. Addi ...
- Basic & Intermediate
- 60 Mins
- Jose Mora
- Sep 08, 2026
Recorded Webinar
ChatGPT / AI and Project Management for FDA-Regulated Companies
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
Recorded Webinar
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
On-Demand Webinar
DHF (Design History File),DMR, DHR, Technical Documentation Files – US FDA and EU MDR Requirements
This webinar will examine the existing requiements for the US FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
Recorded Webinar
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR ...
- Basic & Intermediate
- 60 Mins
- Jose Mora
Recorded Webinar
Validation of GC/ GC-MS Methodologies
Instrumental gas chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation ...
- Intermediate
- 90 Mins
- John Fetzer
Recorded Webinar
Audit 101 - How to conduct an effective audit & what they don't tell you may happen during an audit
Auditing is a critical function in any organization, ensuring compliance, accuracy, and efficiency in various operations. While traditional auditor certification training provides a solid foundation in auditing principles, procedures, and standards, it often f ...
- Intermediate & Advan
- 90 Mins
- Meredith Crabtr
Recorded Webinar
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
Recorded Webinar
Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push ...
- Intermediate
- 90 Mins
- Jose Mora
Recorded Webinar
Supervising a Human Error Free Environment: You can do a Lot More than you think
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Intermediate
- 90 Mins
- Ginette Collazo