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304 results of "Life Sciences x"
Live Webinar

Project Management for FDA-Regulated Companies

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 ...

Live Webinar

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with ...

  • Basic & Intermediate
  • 60 Mins
  • Roger Cowan
  • Dec 14, 2021
Live Webinar

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one. You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, ...

Live Webinar

Non-conforming Materials and Failure Investigations for Medical Devices

Non-conforming material happens.  And medical device companies must deal it.  This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material.  You will learn where non-conforming material can occur ...

Live Webinar

EPCRA TRI Form "R" Reporting

This training program will help attendees understand the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxic Release Inventory (TRI) Form R reporting requirements. It will also elucidate what the EPCRA TRI Form R is, when they are required to be f ...

  • Basic & Intermediate
  • 60 Mins
  • Joe Keenan
  • Dec 20, 2021
Live Webinar

QMS Structure and SOP Writing Essentials

Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures.  That requires translating requirements into professionally written SOPs with adequate level of detail on how to do things.  Excellent SOPs need mor ...

Live Webinar

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...

Live Webinar

How to manage an FDA Inspection

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during regulatory inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections effic ...

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 ...

Live Webinar

Forecasting When Nothing Will Ever Be Like Before

A commonplace to start with is that deterministic systems can be forecasted, and then all what is uncertain can be compared to dice throwing, and belongs to the world of stochastics. Give somebody a hammer, and everything will seem to him like a nail. However, ...