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235 results of "Life Sciences x" and "FDA Compliance x"
Live 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 ...

Live Webinar

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 ...

Live Webinar

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 ...

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 ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

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 ...

Live 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
  • José Mora
  • Nov 20, 2020