Data Integrity Audits and Inspections - Online Training Recording

Costs

*ECA-Member:**	EUR 1590,--
*Regular Fee:**	EUR 1790,--
*EU/GMP Inspectorates:**	EUR 895,--
*APIC Member Discount:**	EUR 1690,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Danny De Scheemaecker, Janssen Pharmaceuticals
Dr Franz Schönfeld, GMP Inspector
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche
Francois Vandeweyer, formerly Janssen Pharmaceuticals

Objectives

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.

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 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:

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:

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.

Programme

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

Go back