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421 results of "Life Sciences x"
Live Webinar

CAPA Under U.S. FDA / CGMPs and EU MDR / ISO

CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus. The roles of Failure Investigation ...

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
  • Oct 16, 2019
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

Understanding Initial IND Submission- The first 30 days

This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical ...

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

SOPs for Commercialization

This webinar will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within th ...

Live Webinar

FDA’s New Approach in Regulating Medical Software

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

Are You Ready for a FDA Preventative Controls Audit?

This course will examine new FDA authority, introduces examples of Preventative Controls, leading into minimal recommended preparation steps for handling the new FDA FSMA requirements, including managing Form #483, or the FDA Warning for non-compliances. 

  • Basic & Intermediate
  • 60 Mins
  • Gina Reo
  • Oct 28, 2019
Live Webinar

US FDA’s 2019 - 2020 Strategic Priorities

In their latest strategic priority cycle, the FDA has committed to reduce the time and cost required to bring a product to the U.S. market and support it throughout its life cycle while not compromising reasonable assurance of safety and effectiveness. To achi ...

Live Webinar

FDA Quality System Regulation - Guidelines on Validating Analytical Methods and Processes

In this webinar you will learn the FDA’s expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. We ...