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Validity : 30th Nov'23 to 10th Dec'23
Search Trainings
Live Webinar
FDA - ICH Guideline Q9 R1 on Quality Risk Management
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application ...
- Basic & Advanced
- 90 Mins
- Meredith Crabtr
- Dec 05, 2023
Live Webinar
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Dec 07, 2023
Live Webinar
Medical Device Cybersecurity and FDA Compliance
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Dec 11, 2023
Live Webinar
Fair Debt Collection Practices Act (FDCPA)
The FDCPA is a federal act that provides consumers with information around debt collection. Third party debt collectors have to abide by the regulations
- Basic & Advanced
- 60 Mins
- Justin Muscolin
- Dec 20, 2023
Live Webinar
US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485
The United States Food and Drug Administration (FDA) plays a crucial role in regulating medical devices to ensure their safety and effectiveness. In an effort to harmonize its regulatory framework with international standards, the FDA has proposed aligning its ...
- Basic & Advanced
- 90 Mins
- Meredith Crabtr
- Dec 20, 2023
Live Webinar
Risk-based Design Control - The New Paradigm for Medical Device Design
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. Design control is not only a requirement of t ...
- Intermediate
- 60 Mins
- José Mora
- Jan 10, 2024
Live Webinar
An Advanced Course on Lean Documents, Lean Configuration, and Document Control
In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...
- Basic & Intermediate
- 90 Mins
- José Mora
- Jan 29, 2024
Live Webinar
Risk Management for Medical Devices per ISO 14971 2019
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project, any new consi ...
- Intermediate
- 60 Mins
- José Mora
- Mar 12, 2024
Recorded Webinar
Current GXP expectations on Water system validation compliance
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...
- Basic & Intermediate
- 90 Mins
- Hitendra Kumar
Recorded Webinar
Best Practices in Preparation for an FDA Audit of Regulated Computer Systems
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 ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano