Tips for Setting up Your Team for Inspection

 

Data Integrity App

 

In Earlier post we understood Do’s and Don’ts During FDA Inspection in Pharma Industry?

Now in this article we are going to understand Tips for Setting up Your Team for Inspection.

Tips is designed and built to empower teams

 Inspectors Team vs Your team for inspection
 
Inspectors Team
Consists of one lead inspector & assisting inspector(s). Where appropriate, one or more technical specialists may be included.

Lead inspector is responsible for leading inspection & compiling inspection report.
May also include inspector trainees or observers.

All inspection team members are bounded by obligations of confidentiality.
 
Setting up your team for inspection
 
Good team is essential for high performance in any organization. Teamwork is Improved Efficiency, Quality & Higher Morale of organization.
 
 
Consider below points before setting team for inspection.
ü  Identify Team Members
ü  Find Strength & Weakness
ü  Assign Roles
ü  Provide Training
ü  Review the scope of Inspection
ü  Conduct a Simulation (Mock Inspection)
ü  Practice document requests
 

Inspectional Objectives

 1. Verify that a quality policy, management review and quality audit procedures, quality plan, and quality system procedures and instructions have been defined and documented.

2. Verify that a quality policy and objectives have been implemented.

3. Review the firm's established organizational structure to confirm that it includes provisions for responsibilities, authorities and necessary resources.

4. Confirm that a management representative has been appointed. Evaluate the purview of the management representative.

5. Verify that management reviews, including a review of the suitability and effectiveness of the quality system, are being conducted.

6. Verify that quality audits, including re-audits of deficient matters, of the quality system are being conducted.

At the conclusion of the inspection....

 7. Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained.
 

“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App

 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 

Data Integrity App Link:

https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.