GLP FDA Inspection CONTENT Package

If you need training/reference material on preparing for an FDA GLP inspection, this is the content package for you. This package includes a comprehensive two-part reference (baseline guide) article, PowerPoint training presentation and trainer instructional notes and FAQ and answers document.

➢ 1. Preparing for an FDA GLP Inspection: Part I (Article)

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➢ 2. Preparing for an FDA GLP Inspection: Part II (Article)

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➢ 3. Preparing for an FDA GLP Inspections (PowerPoint Presentation)

➢ 4. Preparing for an FDA GLP Inspections (Trainer Instructional Notes)

➢ 5. GLP Amendments and Deviations: Frequently Asked Questions and Answers (Bonus FAQ)

1. Preparing for an FDA GLP Inspection: Part I (Article)

Preparing for an FDA GLP Inspection - Part I

Serves as a baseline guide for preparing for an FDA Good Laboratory Practice inspection. A number of topics are reviewed, including typical target areas FDA will inspect:

➢Equipment andequipment controls

➢facility controls

➢Part 11 compliance

➢record retention

➢quality assurance unit

➢Study Director

➢CAPA, etc.

➢13 determinations that an FDA investigator must make during a nonclinical study testing facility inspection.

➢FDA's regulatory authority to conduct inspections of nonclinical laboratory testing facilities

➢IND submissions, FDA's BIMO program for nonclinical studies

➢ALCOA and much more.

2. Preparing for an FDA GLP Inspection: Part II (Article)

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A number of topics are reviewed including:

➢Division of Scientific Investigations

➢The FDA Field District Office

➢Anatomy of an FDA GLP Inspection

➢Four (4) Types of Inspections

➢FDA Sampling Plan for GLP Inspections

➢Routine vs. "For Cause" Inspections

➢Management of FDA Inspections at Nonclinical Study Testing Facility Sites

➢FD-483 Turbo EIRs

➢FDA's Position-Internal Audit Reports

➢Top 5 Bioresearch Monitoring FDA Inspectional Observations for Nonclinical Study

➢Testing Facility Inspections

➢Post Inspection

➢and more

3.& 4. Preparing for an FDA GLP Inspections (PowerPoint Presentation and Trainer Instructional Notes)

➢17 slide PDF PowerPoint Training Presentation

➢Based on the subject matter presented in the reference content two-part article series above.

➢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.They are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.

5. GLP Amendments and Deviations: Frequently Asked Questions and Answers (Bonus FAQ)

Excursions from GLP procedures, such as protocols, standard operating procedures, and test methods, can be problematic and impact the integrity of the GLP study. Simple strategies can be easily implemented to avoid procedure pitfalls by preventing or minimizing the potential for excursions to occur in the first place. Because of the nature of GLP studies, procedural excursions inevitably do and will occur. When they do occur, proper documentation of amendments, deviations, unforeseen circumstances and unusual events are crucial to the reconstructibility of a GLP study and the quality and compliance of the study report. Responses to ten frequently-asked questions related to excursions which occur in the real world of GLP are presented.

GLP FDA Inspection CONTENT Package only $99.00