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304 results of "Life Sciences x"
Live Webinar
21 CFR Part 11 Electronic Records/Signatures
The Webinar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes developing a company philosophy and approach ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jul 05, 2022
Live Webinar
Project Management for Non-Project managers
Today more than ever before the job titles that we hold are not entirely reflective of the work that we do. Global teams and collaboration often place those in positions of team leadership that have the least foundation to manage all facets of complex project ...
- Basic
- 90 Mins
- Charles H. Paul
- Jul 06, 2022
Live Webinar
Test Method Validation to Verify your Device Performance
This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements, and how to perform successful TMV to ensure your inspection of verification is effectiv ...
- Basic & Intermediate
- 60 Mins
- José Mora
- Jul 08, 2022
Live Webinar
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, tem ...
- Basic & Intermediate
- 60 Mins
- Roger Cowan
- Jul 12, 2022
Live Webinar
How to comply with the FDA’s Quality System Regulation 21CFR Part 820
21 CFR Part 820, known as the Quality System Regulation QSR outlines the Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, in ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Jul 12, 2022
Live Webinar
Pharmaceutical Compressed Air:Quality GMP Standards and Requirements
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system are essential for maintaining a quali ...
- Intermediate
- 60 Mins
- Roger Cowan
- Jul 22, 2022
Live Webinar
Best Practices for Preparing for an FDA Computer System Audit
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer sys ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jul 25, 2022
Live Webinar
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance
This interactive webinar explains how to configure and validate GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...
- Basic & Intermediate
- 75 Mins
- David Nettleton
- Jul 27, 2022
Live Webinar
Human Error and Management Systems: Designing Errors Out
If you work in the GMP regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Jul 28, 2022
Live Webinar
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Aug 16, 2022