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

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.  Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...

Live Webinar

Compliance for Risk Based Approaches for clinical trials including the New FDA RBM Guidance 2019

Risk management is becoming increasingly important for running clinical trials. There are now numerous pharmaceutical guidelines covering risk assessment and management and Risk-Based Monitoring (RBM) including the revised ICH GCP R2 guideline, EU Clinical Tri ...

  • Basic & Intermediate
  • 60 Mins
  • Laura Brown
  • Jul 18, 2019
Live Webinar

FDA’s Evolving Approach to Medical Software Regulation

As technology continues to advance in all areas of healthcare, the software has become an essential part of virtually all products, integrated widely into digital platforms that serve medical purposes The FDA has recognized its traditional approach to devic ...

Live Webinar

Allergen Cleaning, Validation & Preventative Risk Management

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

  • Basic & Intermediate
  • 60 Mins
  • Gina Reo
  • Jul 23, 2019
Live Webinar

Secrets to Writing Effective SOPs

Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures.This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective.You will learn techniques for creati ...

Live 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 ...

Live Webinar

Controlled Document System for a Life Sciences Manufacturing Plant - 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. Life science manufacturing plants have the additional responsibi ...

Live Webinar

Understanding the EU Medical Device Regulation

The official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation have been released. The current MDR stands at 350 pages and is a complex array of regulations written in the normal legalese. There are many changes that anyone d ...

Live Webinar

ISO9001:2015 Quality Management Systems: New Concepts - Follow-up

Did you define the context of your organization accurately How well did you apply the seven QMS principles How well did the management team take up their responsibility for delivering quality across the organization A recap of the new high-level structure ...

Live Webinar

EN/IEC 62304 - Is your Medical Device Software Out of Compliance?

This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for ...