All times mentioned are CET.
Sprecher
Stephan Dresen, Daiichi Sankyo Europe
Zielsetzung
- How to control blank forms and templates
- How to maintain Data Integrity for physical, hybrid and electronic records
- How to establish a compliant and pragmatic change control process
- How poor documentation practices and falsification can be detected
- How to train staff in Good Documentation Practice and Data Integrity
- How multilingual documents can be managed and controlled
- How to avoid typical documentation failures
Hintergrund
Both FDA and UK’s MHRA have reacted to this situation by issuing guidances containing clear provisions regarding Data Integrity and documentation e.g. FDA’s CPG objective 3 which covers the laboratory Data Integrity audit or MHRA’s Guidance for Industry on Data Integrity. Also WHO has published a guidance which provides provisions for data governance and contains expectations for records in both paper and electronic forms.
Zielgruppe
Technical Requirements
For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Data Integrity Principles
- Basements of Data Integrity
- Guidelines
- Implementation of Data Integrity Standards at a Side (Praxis Example)
- CARs Model (Critical Application Risks) – an implementation model based on Quality Risk Management
- Examples from current inspections
- Potential CAPAs on observations
- Watch-Outs and defense packages
- Inspectors expectations from different authorities: FDA, ANVISA, MHRA, German MoH …
- Instructions and blank forms – Life cycle and Data Integrity considerations
- FDA requirements for control
- Process for creation of master templates
- Process for operational use of blank forms
- Reconciliation mechanisms
Control of Templates and Blank Forms
Records – Life Cycle and Data Integrity Issues
- GMP Record Lifecycle
- Control Mechanisms
- Data Integrity for physical vs. electronic Records
- How to manage record copies without violating Data Integrity rules?
- How to establish a compliant and pragmatic change control process?
- The GMP Document Roadmap
- Document inventory and reconciliation
- Industry best practice for record retention timelines - GMP requirements vs. Knowledge Management
Management Systems: Paper-Based – Hybrid – Electronic
- Data Integrity expectations on an Electronic Document Management System (EDMS) and Change Control System
- Audit Trail Review / Log File Review
- Fundaments of a modern EDMS
- Traceability
- Mapping ALCOA principles on EDMS and Change Control
- Expectations from Inspections
- What exactly is an electronic signature?
- Advanced vs qualified digital signature
- Technical implementation
- Change of Workflows
- Parallel processes
- How to manage replacements
- Chapter 4 and 21 CFR 11 regulations for linking signatures to electronic records
- Are you saving the underlying electronic record?
- Checks and technical controls to ensure the signature are linked to the record
- Common pitfalls in record-signature linking
- Importance of a second person review for Data Integrity
- What will a reviewer review with paper, hybrid and electronic records?
- Training for second person review
- Detection of poor documentation practices and falsification
- Risk-based second person reviews of records and audit trails
- Pre-requisites: Data Integrity policy with effective training
- Procedure for good documentation practices is essential
- Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding
- Analysis of FDA 483 and warning letter citations for poor documentation practices
- Identification of top 5 documentation failures
- Ways to avoid them e.g. through changes in working practice, training and technical controls
- Part 1: Basics
- Workbench
- Translation
- Synchronisation
- Part 2: Implementation and Management
- Responsibilities
- GMP status
- Versions
- Signatures
- Change Control
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