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Speaker |
David Nettleton |
Industry |
Pharmaceuticals |
Speciality |
Pharmaceuticals |
Available |
All Days |
Duration |
120 Minutes |
Description
This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.
This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.
Learning Objectives
Why Should You Attend
Avoid the 6 most common problems associated with Part 11 and Annex 11 compliance. Learn how to efficiently create the specific documents required to implement data integrity requirements.
Who Should Attend
(5667778)
David Nettleton CPMSM, PESC is an expert in credentialing and provider/payer enrollment with over 23 years of experience in the healthcare industry. David Nettleton has a deep understanding of Medicare & Medicaid enrollment and is a nationally certified credentialing manager and provider enrollment specialist. Through, YS Credentialing PLLC, David Nettleton helps organizations develop and implement best practices guidelines and processes. Guides the credentialing and payer enrollment structure. Thrives on training and growing administrative, credentialing and enrollment healthcare professionals.