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330 results of "Life Sciences x"
Live Webinar

How Medicare’s Market-Based Payment System Is Upending the U.S. Clinical Laboratory Industry

Starting in 2018, Medicare reimbursement for most high-volume and many other laboratory tests are seeing reductions of up to 10 per cent for each of the next three years, followed by up to 15 per cent for each of the next three years as required by the Protect ...

Live Webinar

Technical Writing in an Industrial Environment

Technical Writing in an Industrial Environment differs from general correspondence in that it is written for a specific audience. It is a balancing act between being precise enough to cover the subject matter yet general enough to apply to other locations and/ ...

Live Webinar

Laboratory Investigation of Out-of-Specification (OOS) Results

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. Sp ...

Live Webinar

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas will be discussed; incl ...

Live Webinar

Investigating OOS results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...

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 a ...

Live Webinar

Preventative Controls for Allergen Risk Mitigation Under FSMA

A five-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 fo ...

  • Basic & Intermediate
  • 60 Mins
  • Gina Reo
  • Apr 25, 2019
Live Webinar

FDA Rules for Pharmaceutical Analytical Method Validation

FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they ...

Live Webinar

cGMP Water Systems – How to Avoid Their Typical Emergencies & Problems

Pharma cGMP Water Systems are very critical to the safe production of medicines for patients. Several Departments are required for continued High-Quality operations. These include Quality, Manufacturing, maintenance and Validation on a daily basis. This presen ...

Live Webinar

Compliance with the New ICH GCP Revision 2 Addendum – Know the How?

This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites. This will enable y ...

  • Basic & Intermediate
  • 60 Mins
  • Laura Brown
  • May 01, 2019