Dr. Franz Schönfeld
Regierung von Oberfranken
Referent:innen
Francois Vandeweyer
VDWcGMP Consulting
Dr. Wolfgang Schumacher
formerly F. Hoffmann-La Roche
Zielsetzung
In this training course you will get to know the practical and proven techniques for conducting effective self-inspections/audits of various pharmaceutical operations to identify the critical deficiencies associated with Data Integrity. A combination of presentations and case studies will be offered to provide a maximum learning experience.
All important elements of Data Integrity inspection, the Data Integrity self-inspection and the customer Data Integrity audit processes will be discussed. Furthermore, you will be informed about the importance of Data Integrity for the daily business in all areas of the company. Moreover, you will obtain a comprehensive overview of the regulatory requirements and recent audit and inspection trends.
As a production, QA or QC professional you will benefit by learning what the potential problem areas are – so you can take appropriate actions. You will become familiar with the audit tools that are available to you. And you will also have a chance to review and discuss current GMP compliance issues with the speakers.
All important elements of Data Integrity inspection, the Data Integrity self-inspection and the customer Data Integrity audit processes will be discussed. Furthermore, you will be informed about the importance of Data Integrity for the daily business in all areas of the company. Moreover, you will obtain a comprehensive overview of the regulatory requirements and recent audit and inspection trends.
As a production, QA or QC professional you will benefit by learning what the potential problem areas are – so you can take appropriate actions. You will become familiar with the audit tools that are available to you. And you will also have a chance to review and discuss current GMP compliance issues with the speakers.
Zielgruppe
The training course is designed for QA, QC and production professionals as well as GMP auditors who intend to specialize in Data Integrity auditing and who are facing FDA and EU inspections.
It is further intended for professionals who are responsible for GMP Compliance and Auditing, at both the beginner and advanced levels. Regulatory professionals who are responsible for FDA inspections should also attend. All attendees will gain practical knowledge in establishing an effective Data Integrity compliance audit program
It is further intended for professionals who are responsible for GMP Compliance and Auditing, at both the beginner and advanced levels. Regulatory professionals who are responsible for FDA inspections should also attend. All attendees will gain practical knowledge in establishing an effective Data Integrity compliance audit program
Technical Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programm
Data Integrity Inspections from the Inspector's Point of View
- Data Integrity inspections as part of general GMP inspections
- What the inspectors look at
- Typical findings at Data Integrity inspections
- Electronic documentation and paper documentation
Critical Data – Which Ones must be Audited?
- Static vs. dynamic data
- Direct vs. indirect impact data
- GMP – GLP – GCP – GDP data
- Critical service provider data
Quality System / Data Governance Self-Inspection
- The PQS
- Data governance
- DI Risk assessments
- The Data Integrity program
Real Life Practical Examples (non Lab related)
- Introduction presentation
- Example 1: Production batch records
- Example 2: Calibration records
- Example 3: Rejected batches
Laboratory Data Integrity Inspections
- Lab risk-based approach
- LIMS challenges
- Supplier pre-set lab equipment
- Logbooks
Informatics (IT) Self-Inspections
- Key questions to be asked in IT departments
- The role of IT in Data Integrity
- Key Data Integrity requirements for software
Production Self-Inspections
- ISA 95 systems
- APIs/dosage forms
- Chemical vs. Biotechnology
- CPP - Design Space Parameters
How to Develop an Agenda for an Audit of a SaaS Service Provider
- Scope and audit team
- What to check?
- Critical areas / Security / Data privacy
How to Leverage the ISO 19011 Section for Remote Audits to the GMP Area
- Pros and cons of remote audits
- Definition in the audit SOP and the annual audit program
- Remote audit process
Risk-based Data Integrity Assessments
How to identify gaps in your system:
- Business process mapping
- Data and system categorisation, including System assessment
- Risk assessment and remediation
- Some examples
Data Integrity (Self) Assessments
How to identify and detect potential risks for Data Integrity failures:
- Area/ processes /system to cover
- Specific questions to consider
Two Data Integrity Checklists!
All participants will receive two Data Integrity checklists. One checklist has been developed by APIC/CEFIC, the second checklist has been developed by ECA´s Data Integrity IT Compliance Group. Both checklists will be available in electronic format for daily use!
Recording from 12/13 October 2021
Duration of Recording: 7h 41min
Duration of Recording: 7h 41min
| ECA-Member*: | € 1590,- |
| Regular Fee*: | € 1790,- |
| EU/GMP Inspectorates*: | € 895,- |
| APIC Member Discount*: | € 1690,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager"
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E-Mail: info@concept-heidelberg.de
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