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316 results of "Life Sciences x"
Live Webinar

FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP)

This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of what not to do.

Live Webinar

Technical Writing: Best Practices

Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. The term is primarily associated with the pharmaceutical and medical devices industries but applies to documents creat ...

Live Webinar

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs.  These design inputs then form the basis of the design specification, which becomes the design output.  Since design ...

Live Webinar

Environmental Monitoring for Pharmaceutical Clean Rooms

This webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program, Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine EM using Facility V ...

Live Webinar

The Pharmaceutical Quality System: An element of Contemporary Compliance

The term Quality System began appearing in FDA publications and guidance about the turn of the century. In 2008 the FDA and ICH released ICH Q10, The Pharmaceutical Quality System and many of the FDA publications are based on the Quality System philosophy. The ...

Live Webinar

Best Practice for Complaint Handling in Compliance with FDA and ISO Regulations

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may dete ...

Live Webinar

Knock, Knock, Who’s There? Preparing for an FDA Inspection

Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage i ...

Live Webinar

Steam Sterilization Microbiology and Autoclave Performance Qualification

In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization proc ...

Live Webinar

New GCP Compliance Requirements for Clinical QMS

Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based. Reg ...

  • Basic & Intermediate
  • 60 Mins
  • Laura Brown
  • Apr 02, 2019
Live Webinar

Data Integrity and Privacy: compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...