WEBINARS

 

Biotechnology Documentation and IT Regulatory Compliance Training - Live Webinars, Recordings & CDs

Key Factors to Develop an Effective CAPA System

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 703320

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

Recording Available

 

Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 705081

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

Recording Available

 

The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704734

This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.

Recording Available

 

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704533

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Recording Available

 

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