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93 results of "Life Sciences x" and "Clinical Research 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

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

Current Trends in Cyber security Threats for Medical Devices

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 ...

Live Webinar

Advertising and Promotional material compliance and review process

The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, stra ...

Recorded Webinar

Medical Device Cyber-security following latest FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market.The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communi ...

Recorded Webinar

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reac ...

Recorded Webinar

Effective Standard Operating Procedure (SOPs) Development

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.  

On-Demand Webinar

FDA Internal Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages.The webinar will address aspects of the review process, SOP p ...