Data Integrity Audits and Inspections - Live Online
12/13 October 2021
Course No. 19135
Speakers
Dr. Franz Schönfeld
Regierung von Oberfranken
Francois Vandeweyer
VDWcGMP Consulting
Dr. Wolfgang Schumacher
ehem. F. Hoffmann-La Roche
All times mentioned are CEST.
Objectives
In this Live Online Training 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.
Target Group
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
Technical Requirements
For our Live Online Training Courses 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.
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
Discussion, Q&A
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!
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more
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Testimonials
Seminar Programme as PDF