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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
- Oct 26, 2020
Medical Device Reporting and Recall Management
Despite best efforts, serious quality issues resulting in the recall can occur. Medical Device companies need to be prepared in advance to handle the difficult situation. This webinar will prepare you to understand the signals that trigger a need to recall, th ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Oct 28, 2020
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas will be discussed; incl ...
- Intermediate
- 90 Mins
- Kelly Thomas
- Nov 09, 2020
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 ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Nov 10, 2020
Compliance with Telemedicine Issues
Telemedicine has both benefits and drawbacks, both to practitioner and to patients. One of the drawbacks is, similar to healthcare in general, the over-regulation of telemedicine. This webinar will discuss all of the compliance areas, licensure requirement as ...
- Basic & Intermediate
- 60 Mins
- Jonathan P. Tom
- Nov 10, 2020
Remote Auditing of Medical Device Suppliers During Covid-19
The Covid19 pandemic has caused sudden disruption to the supplier management programs for many medical device companies. This webinar will help you update your approach to supplier auditing during the challenges of Covid19. This webinar can help you understand ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Nov 12, 2020
CMO Supplier Quality Agreements: How to Comply with new FDA and EU Guidelines for Contract Drug Manufacturers
In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well-publicized quality issues with CMOs, make it a necessity ...
- Intermediate
- 60 Mins
- Roger Cowan
- Nov 12, 2020
Useful Statistical Methods for Defining Product and Process Specifications
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time. If specifications are too wide, the risks of inadequa ...
- Basic & Intermediate
- 90 Mins
- Steven Wachs
- Nov 13, 2020
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
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
- Nov 17, 2020
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
- José Mora
- Nov 20, 2020