GMP CONTENT Packages

➢Part 211 Drug GMP: e-Textbook

This e-textbook contains over 280 pages; 30 individual documents from subparts B-K.  Each subpart includes: Reference Article, PDF PowerPoint Presentation, Trainer Instructional Notes, Audit Checklist   Read More - Click Here...

➢NEW Subpart F Production and Proress Controls PACKAGE - Click Here

➢Basics of Drug GMP CONTENT Package

Over 70 Pages of exclusive "how to" Articles, PowerPoint Training Presentations and a Webinar Recording. Read More - Click Here...

➢DEA Regulations CONTENT Package

Includes an article, one hour webinar recording, PowerPoint training presentation Read More - Click Here...

➢Managing FDA GXP Inspections CONTENT Package

This 200+ slide PDF PowerPoint training presentation is a complete training document on reviewing FDA’s inspectional process to executing an FDA GXP inspection from planning through post GXP inspections. Also included in this package the comprehensive SOP "Management of Regulatory Agency Inspections"  Read More - Click Here...

➢Process Validation CONTENT Package

This package contains LIVE ONLINE recording, PowerPoint Training Presentation, Auditing Checklist, 2 Reference Articles and a Training Script. Read More - Click Here...

➢FDA GMP Inspections CONTENT Package

This package contains 8 content elements in preparing for and successfully executing FDA inspections related to CAPA, change control, Part 11 (Electronic Records and Signatures) and includes: 3 Webinar recordings, 3 PowerPoint training presentations, 2 reference articles (21 pages).  Read More - Click Here...

➢Change Control CONTENT Package

A one hour webinar recording, PDF PowerPoint presentation, audit checklist, FAQ and Answers document and a DVD Interview Read More - Click Here...

➢Batch Record Review CONTENT Package

An integrated package that includes a must read article, SOP, Audit Checklist, Form and PowerPoint training presentation and trainer instructional notes. Read More - Click Here...

➢Failure Investigation CONTENT Package

"Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. 211.192}"  is a citation we see over and over again in FDA Warning Letters. This package will provide guidance to help meet specific FDA Requirements.

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➢Supplier Quality Agreements CONTENT Package

Over 40 Pages including an article, SOP, Template, PowerPoint presentation, and a DVD Interview. Read More - Click Here...

➢CAPA CONTENT Power Package

Package includes three webinar recordings, three PowerPoint presentations, over 50 pages of exclusive "how to" articles, SOP template, two checklists, and form: Read More - Click Here...

➢Complaint Handling CONTENT Package

70 Pages of exclusive "how to" article with bonus material, compliance narrative, SOP template, Checklist and PowerPoint training presentation. ReadMore - Click Here...

➢Supplier Qualification CONTENT Package

20 page article, an assessment plan with over 80 individual items over 20 major compliance areas, PowerPoint training presentation and trainer instructional notes Read More - Click Here...

➢Cleaning Validation SOP Template Package

With this package you receive three cleaning validation SOP templates, 25+ pages, 100+ key procedure steps to performing cleaning validations and its documentation. Read More - Click Here...

➢Pre-Qualification SOP Template Package

With this package you receive 6 SOP templates, 4 flow charts, 3 pre-qualification activity flowcharts - 35+ pages of SOP Templates. Read More - Click Here...

➢Applying SOPs in GXP Operations Content Package

This article presents how SOPs are applied in a GMP, GCP and GLP regulatory environment. Read More - Click Here...

➢An Auditor's Toolkit: GMP Requirements

12 checklists, SOPs, and forms (40+ pages) related to Quality Systems. Read More - Click Here...

➢GMP SOP CONTENT Power Package

This package contains 18 content elements (125+ pages) related to CAPA, complaint handling, internal audits, batch records, quality agreements and SOP on SOPs, including: 7 SOP templates (55 pages), 4 SOP template auditing checklists (20 pages), 3 Forms (3 pages), 2 Other Templates (11 pages), 1 PowerPoint Training Presentation and Trainer Instructional Notes (30 pages) and 1 Article (8 pages) Read More - Click Here...

➢IND/NDA Regulatory Submission Checklist - Guide

This 21 page checklist - guide document provides over 220 items related to performing an effective audit of Chemisty, Manufacturing and Controls (CMC) section of the followiing: Investigational New Product (IND), IND Amendments, New Drug Application (NDA), NDA Amendments, NDA Supplements and Annual Reports. Read More - Click Here...

➢More than just SOPs: Defining the Documentation Lifecycle that Best fits Your Organization

This training will help answer the question of what level of documentation is required to effectively meet the needs of your organization...Read More - Click Here...

➢Software Supplier Auditing CONTENT Package

Includes a Webinar Recording, PowerPoint Training Presentation, Audit Checklist, frequenty asked questions and answers. Read More - Click Here...

➢Computer Validation CONTENT Power Package

Package contains 10 items including: 2 webinar recordings, 3 PowerPoint presentations (60+ slides), 2 trainer instructional notes, and 3 reference articles (30+ pages). Read More - Click Here...

➢Part 11 CONTENT Power Package

Package includes three webinar recordings, three PDF PowerPoint presentations and a compliance assessment checklist Read More - Click Here...