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Live Webinar
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Jan 25, 2022
Live Webinar
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with ...
- Basic & Intermediate
- 60 Mins
- Roger Cowan
- Feb 08, 2022
Live Webinar
The new Part 11 inspections: requirements for validation and SaaS/Cloud applications.
Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...
- Basic & Intermediate
- 90 Mins
- David Nettleton
- Feb 15, 2022
Live Webinar
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance
This interactive webinar explains how to configure and validate a 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 ...
- Basic & Intermediate
- 75 Mins
- David Nettleton
- Mar 22, 2022
On-Demand Webinar
NFPA 70E Arc Flash Training
This webinar training will define what an arc flash is and discuss how to prevent it from occurring. It will offer participants an understanding of the regulatory requirements of the NFPA 70E standard and detail how it applies to your facility. Participants wi ...
- Basic & Intermediate
- 60 Mins
- Joe Keenan
Recorded Webinar
Reducing Memory and Attention Failures/Errors: Cognitive Load Assessment
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage and usu ...
- Intermediate
- 90 Mins
- Ginette Collazo
On-Demand Webinar
Human Error Reduction In GMP Manufacturing/Floor
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From p ...
- Intermediate
- 90 Mins
- Ginette Collazo
Recorded Webinar
Avoiding Death by CAPA (Corrective and Preventive Action)
We’ll discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection. This webinar will help you ...
- Intermediate
- 90 Mins
- Susanne Manz
On-Demand Webinar
FDA Regulation of Artificial Intelligence & Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and g ...
- Basic & Intermediate
- 60 Mins
- José Mora
Recorded Webinar
Spotlight on Complaint Handling and Medical Device Reporting
Complaint management and Medical Device Reporting (MDR) are critical quality systems for you to meet the needs of your 3 key stakeholders – the customer, the regulators, and your business. This webinar will help you to understand the expectations of complaints ...
- Intermediate
- 90 Mins
- Susanne Manz