QMS Remediation in Pharma: : A Practical Guide to Restoring Compliance and Building Resilient Quality Systems

By Jonathon Rochelle

Description:
QMS Remediation in Pharma: A Practical Guide to Restoring Compliance and Building Resilient Quality Systems is a vital resource for QA professionals, regulatory experts, consultants, and executives tackling pharmaceutical QMS challenges. Written by Jonathon A. Rochelle, a QA leader with 25+ years of experience in Consent Decree remediations, this guide delivers a step-by-step roadmap to turn compliance failures into sustainable strengths.

Structured in five parts, it covers QMS basics and regulatory expectations, planning and gap assessments, core element remediation (e.g., CAPA, data integrity, supplier oversight), execution with project tools and metrics, and post-remediation culture building. Practical features include a stoplight KPI tracking guide, case studies, and appendices with templates like Remediation Master Plans, SOP checklists, and CAPA toolkits.

The book emphasizes risk-based strategies, cultural shifts, and continuous improvement. Ideal for responding to FDA 483s or EMA inspections, it equips readers to achieve robust compliance and resilient systems.

• Format: Paperback
• Language: English
• ISBN: B0FLYMQZ22
• ISBN13: 9798297060883
• Release Date: August 2025
• Publisher: Independently Published
• Length: 446 Pages
• Weight: 2.26 lbs.
• Dimensions: 0.9" x 8.5" x 11.0"