Data Integrity

Data Integrity is a fundamental element of a pharmaceutical industry to ensure quality and safety of drugs. Recently, the FDA and other global regulatory bodies have emphasized the importance of accurate and reliable data in assuring drug safety and quality.

This application will helpful for understanding what Data integrity really means & How 21 CFR Part 11 affects in pharmaceutical Industry.

Objectives:

1) You will get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements

2) You will get a deeper understanding what FDA and other global regulatory inspectors expects from pharmaceutical companies in regard to Data Integrity

3) You will learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System

4) You will learn how to prepare your company for an successful inspection in regard to Data Integrity

5) You will understand how to establish an effective Data Governance system

6) You will learn how to investigate Data Integrity issues in your company

You Will Learn:

1) Basic & Advance Concepts of Data Integrity

2) Computer System Validation Tips,

3) Mock Inspection Question & Answer

4) Checklist for Inspection

5) Industry Best Practices to Maintain Data Integrity

6) Useful Reference & Resources

7) Current Regulatory thinking on Data Integrity

8) SOP

9) Interview Q & A

10) And much, much more…

Who Will Benefit:

1) Pharmaceutical/ Medical device / Healthcare/Life science Industry personnel

2) Validation/ IT Service Providers

3) Developers of software for use in Life Sciences industry

4) Regulatory Affairs, Quality Unit

5) Laboratory personnel

6) Clinical Trial Sponsors

App Content:

Basics:-

1 Data

2 Raw Data

3 Meta Data

4 Transient Data

5 Recording of Data

6 Data Capture/Recording

7 Data Integrity

8 The Principles of Data Integrity

9 Data Lifecycle

10 Data Transfer/Migration

11 Data Processing

12 Data Governance

13 General Data Integrity observation

14 Root Cause of DI

15 Electronic Record

16 Requirements for Electronic Records

17 Electronic Signature

18 Requirements for Electronic Signature

19 Handwritten Signature:

20 Static & Dynamic Record

21 Data Review & Approval

22 Review of Electronic Data

23 Computer System

24 Computerized System Access and Security

25 History of CSV

26 Computer System Validation

27 Software

28 Category of Software

29 Software Requirement & Specification

30 Legacy Systems

31 Open System:

32 Closed System

33 Hybrid System

34 Audit Trail

35 Documentation & Records

36 Original Record

37 True Copy

38 Data Backup & Restore

39 Storage, Archival and Disposal of Electronic Data

40 Archive

41 SOP

42 Personnel Training

Advance :-

1 What is GDPR

2 New FDA Validation Approach CSV to CSA

3 User Requirement Specification

4 GAP Assessment

5 Bridging the GAP

6 Risk Assessment

7 GxP Assets Management

8 GxP Assessment

9 Vendor Assessment

10 Change management

11 Benefits of change control system

12 Deviation

13 Incident

14 CAPA

15 Validation

16 Validation protocol

17 Software Validation

18 Benefits of Software Validation

19 Software Verification:

20 Traceability Matrix

21 Equipment Log management

22 Software Life Cycle Activities

23 Qualification

24 Calibration:

25 Periodic System Evaluation

26 Retirement & Decommissioning Process

27 General Data integrity Observation

Inspection:-

1 Introduction

2 Types of inspection

3 Preparing For Inspections

4 Inspection strategies

5 Mock Inspection

6 Inspection Agenda

7 New Approach of Inspection

8 FDA (Inspectors) Expectations

9 What is QSIT (Quality System Inspection Technique)

10 QSIT Management controls

11 QSIT Design Controls

12 QSIT CAPA Controls

13 QSIT Production and Process Controls

14 Do’s and Don’ts Inspection

15 Setting up the team for Inspection

16 Objective of Inspection

17 WARNING LETTERS

18 FROM 483

19 Whistle-Blowing, The Next Big Wave

All the Best for Better Compliance.

Team Innovative Appz