Engaged. Knowledge. Application
Applying SOPs in GXP Operations Content Package
1. Standard Operating Procedures For GXP Operations: Practical Applications in FDA-Regulated Industry
Click here to view complimentary excerpt
2. SOP for GXP Operations:(PowerPoint Training Presentation)
3. SOP for GXP Operations: (Trainer Instructional Notes)
1.Standard Operating Procedures For GXP Operations: Practical Applications in FDA-Regulated Industry
Click here to view complimentary excerpt
This eight (8) page article presents how SOPs are applied in a GMP, GCP and GLP regulatory environment. The article reviews the following subject matter content below:
➢ The fundamentals
➢ Regulatory basis for SOPs-ICH E6 1.55, 21 CFR 211.22 and 21 CFR 58.81
➢ Benefits of SOPs
➢ Why SOPs?
➢ SOP proof of concept
➢ SOPs for GXP Operations – 21 CFR 211.186 (a)
➢ Defining the written procedure
➢ Strategic implementation
➢ SOP preparation
➢ Sources of content in writing SOPs
➢ Identifying operational needs
➢ GLP SOPs
➢ GMP SOPs
➢ GCP SOPs
➢ SOP design requirements
SOP essential elements
SOP format
Task description
Writing styles
➢ Document control
Change control system
Document management system
Process mapping for SOP development
2. & 3. SOP for GXP Operations: PowerPoint Training Presentation and Trainer Instructional Notes
Fifteen (15) slide PDF PowerPoint Training Presentation
Based on the subject matter presented in the above-referenced content article
This PDF readymade presentation provides “core” subject matter content, and allows you to customize specific information within your presentation. Trainer instructional notes, which contain 30+ discussion points related to the PowerPoint training presentation, are also included.
Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.
Applying SOPs in GXP Operations Content Package is only $99.00
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