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Validity : 21st Jul'21 to 31st Jul'21
Search Trainings
Live Webinar
Excel Spreadsheets; Ensuring Data Integrity and 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
- Jul 29, 2021
Live 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
- Jul 30, 2021
Live 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
- Aug 10, 2021
Live 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
- Aug 11, 2021
Live 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
- Aug 16, 2021
Live 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
- Aug 24, 2021
Live Webinar
How To Conduct A Human Factors/Usability Validation
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quanti ...
- Advanced
- 60 Mins
- José Mora
- Aug 26, 2021
On-Demand Webinar
Metrics and Management Review
Many medical device companies are surprised when they have a recall, a 483, or even a warning letter. To prevent these quality and compliance issues, a company needs to have an efficient and effective Quality Management System (QMS) including good metrics and ...
- Basic & Advanced
- 90 Mins
- Susanne Manz
On-Demand Webinar
Human Error Reduction Techniques for Floor Supervisors
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 ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
Recorded Webinar
Proper CAPA Management
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...
- Intermediate
- 60 Mins
- Danielle Delucy