Search Trainings

160 results of "Life Sciences x" and "Medical Devices x"
Live Webinar

Qualification of Contract Software Developers based on Practical Experience

This webinar will explain the regulatory requirements and a risk based procedure to qualify and manage suppliers that develop software for your company. The phases of the selection process, from compiling a list of candidate developers through the qualificatio ...

Live Webinar

Process Validation - Overview Of Why And How

This webinar will provide an understanding of FDA and ISO 13485 requirements for process validation and how to implement them. The session will cover the basics of this important topic for those who are new to the quality or new to process validation. It will ...

  • Basic & Intermediate
  • 60 Mins
  • Betty Lane
  • Sep 19, 2019
Live Webinar

Adverse Event Reporting and Product Recalls

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint hand ...

Live Webinar

Implementation and Management of GMP Data Integrity

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hyb ...

Live Webinar

Medical Device Software Verification and Validation

This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

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 ...

Live Webinar

Purchasing Control Essentials for Medical Devices

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Cont ...

Live Webinar

FDA Best Audit Behavior Practices – Do’s and Don’ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, a ...

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

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 ...