Search Trainings

316 results of "Life Sciences x" and "Quality Mangement x"
Live Webinar

21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...

Live Webinar

The Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses

In the development and approval process for new medicines and pharmaceuticals, 2 important tests focus on compounds of low concentrations – impurity and degradation product analyses. Analytically this means identifying these compounds and assessing their amoun ...

  • Basic & Intermediate
  • 90 Mins
  • John Fetzer
  • Jul 14, 2020
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

Allergen Cleaning, Validation & Preventative Risk Management

A three-layered approach to Allergen Management will be described, with the latest approaches for cleaning, Validation, monitoring and Preventative Controls now required under FSMA (Food Safety Modernization Act) to incorporate in your Food Safety Plan. Insigh ...

  • Basic & Intermediate
  • 60 Mins
  • Gina Reo
  • Jul 16, 2020
Live Webinar

ETHICS: BEST PRACTICES AND DECISION MAKING

This webcast is intended to discuss with professionals the importance of ethics in all our business relationships and in the performance of our duties.  We will look at what “ethics” is and discuss processes, procedures, and controls we can use to maintain our ...

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
  • Jul 21, 2020
Live Webinar

Content and Format of an Initial IND submission 21 CFR 312.23

This webinar is designed to help pharma companies through the content and format of every module of the common technical document for an initial IND. The presentation will cover the in depth understanding of the contents of every module in the CTD.

Live Webinar

European Union Device Regulation (EU MDR)

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...

Live Webinar

Project Management Tools for Regulatory Compliance

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time. It w ...

Live Webinar

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most im ...