Engaged. Knowledge. Application
With this package you receive three (3) Cleaning Validation SOP templates, 25+ pages, 100+ key procedure steps to performing cleaning validations and its documentation:
➢1. SOP Template - Generating Cleaning Validation Protocols - to view excerpt click here
➢2. SOP Template - Cleaning Validation Procedure
➢3. SOP Template - Generating Cleaning Validation Reports
1. SOP Template - Generating Cleaning Validation Protocols - to view excerpt click here
This 11 page SOP template provides guidelines on performing cleaning validations. It outlines the contents and requirements of the cleaning validation protocol.
The procedure section of this document contains 60+ key steps to developing an effective cleaning validation protocol.
2. SOP Template - Cleaning Validation Procedure
This 8 page SOP template provides rules and guidelines for executing cleaning validations within the drug industry. It describes the validation prcess, documentation requirements and individuals invovolved.
The procedure section of this document contains 20+ key steps to developing an effective cleaning validation procedure. This document also includes a Cleaning Activity Flowchart for sequence of events.
3. SOP Template - Generating Cleaning Validation Reports
This 8 page report provides guidelines on preparing Cleaning Validation Reports. It outlines the contents and requirements of the CV report.
The procedure section of this document contains 25+ steps in preparing cleaning validation reports.
About the Author
Charlie Neal, Jr., has 30+ years of experience in GMP-regulated industries. He has held lead positions in Research, Development, Process Engineering, Manufacturing, Validation, Quality Assurance and Sales & Marketing. He has acquired hands-on technical experience by working in sterile drugs, solid dosages, liquids, devices, APIs, and biotech industries. He has been responsible for process development, scale-up, optimization, validation, validation strategy development, technology transfers, quality, compliance, validation project management, sales support and sales management. In addition to having strong people management skills, he has developed and maintained quality systems, and proficiency with document management, CAPAs and deviation systems. He also has familiarity with Six Sigma and Lean tools, and experience in conducting and fielding audits.
He has presented papers on Technology Transfers (Japan), validation and validation documentation. He authored a chapter on Transdermal Process Validation, published in the 3rd edition of the technical reference book entitled, “Pharmaceutical Process Validation”. He has held membership on the Editorial Advisory Board for the Journal of Validation Technology since 1998.
Cleaning Validation SOP Templates Package is only $99.00
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