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