價格：免費
更新日期：2019-06-14
檔案大小：4.3M
目前版本：2.1
版本需求：Android 4.0 以上版本
官方網站：mailto:Appzinnovative@gmail.com
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) 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:-
Data, Raw Data:, Meta Data:, Data Integrity, The principles of data integrity, Data capture/recording, Data Lifecycle:, Data Governance , General Data Integrity observation ,Electronic Record, Requirements for Electronic Records, Electronic Signature, Requirements for Electronic Signature, Handwritten Signature: ,Static & Dynamic record ,Computer System, Computerized System Access and Security , History of CSV, Computer System Validation, Software:, Category of Software, Software ,Requirement & Specification, evaluation checklist , Legacy Systems, Open System: , Closed system, Hybrid system, Audit Trail:, Documentation & Records:, Original Record:, True Copy:, Data Backup & Restore:, Data review and approval ,Archive:, SOP & Personnel Training:
Advance :-
GAP Assessment, Bridging the GAP, GDPR, Risk Assessment, GxP Assessment, Vendor Assessment, Change management, Benefits of change control system, Deviation , Incident, CAPA, User Requirement specification,, Validation, Validation protocol , Software Validation, Software verification: ,Benefits of Software Validation, Qualification,, Calibration: , Periodic System Evaluation, General observation
Software Life Cycle Activities,
Inspection:-
Inspection, Types of inspection, Preparing For Inspection, QSIT Quality System, Inspection Technique, QSIT Management controls, QSIT Design Controls, QSIT CAPA Controls, QSIT Production and Process Controls, Do’s and Don’ts inspection , Setting up the team for inspection, Objective of Inspection, WARNING LETTERS & FROM 483.
