GMP meets AI - How to Use Artificial Intelligence in Quality Assurance and Quality Control - Online Training Recording
Course No. 22870
Speakers
Manfred Karner
Takeda
Philip Lienbacher
Takeda
Torsten Kneuss
Bayer
Peter Hackel
Takeda
Dr Frank Hanakam
QuaSyCon Quality Systems Consultancy
Dr Arno Terhechte
GMP inspectorate / Bezirksregierung Münster
Target Group
This seminar is aimed at those responsible in the areas of quality assurance and quality control in the pharmaceutical industry who use AI applications in their areas or decide on their use.
Objectives
In this seminar, you will learn about the possibilities of using artificial intelligence in the areas of quality assurance and quality control in the pharmaceutical Industry.
You will learn
How GPT can be used for daily work with GMP documents
How processes can be automated with the help of AI and digital tools
Which prompting techniques lead to good results
How AI can be used in pharmaceutical quality control
What support AI applications can provide for batch release
You will also receive the latest information from ISPE’s new GAMP AI Good Practice Guide.
Now that the use of artificial intelligence in medical diagnostics has already found its way into the field of imaging procedures, the use of AI applications in the GxP environment is expanding rapidly. Specifically defined chatbots can be used, for example, to search for information on websites. Specially trained GPTs provide support in handling GMP-regulated documents such as qualification/validation documents, stability protocols or trend Reports.
Programme
Use of AI in the GxP Environment from a GMP Inspector’s Perspective
EU GMP Guideline Annex 11
Concept Paper Revision of Annex 11
EMA Reflection paper on the use of Artificial Intelligence (AI)
Guidelines from the pharmaceutical world
Inspection practice
Use of AI in the GxP Environment - what is Required to Generate the Necessary Trustworthiness
Potentials and challenges in the use of AI in the pharmaceutical industry
Current laws and guidelines on AI
Some important AI terms and concepts
Data are the true indicators of Performance
What role do humans play and what roles are required?
From the use case to the right AI system, validation of AI application using a life cycle model
Risk and quality management
Briefing on ISPE’s GAMP AI Guideline
Generative Pre-Trained Transformer (GPT) - Use in the Pharmaceutical Industry
Potential applications
Benefits and challenges
Training and working methods of a GPT
Regulatory aspects
Integration into the corporate application landscape
Use of platforms
Use of own data sources to increase fact security (RAG: Retrieval Augmented Generation)
Steering GPT systems in the right direction (Guardrails)
Use of AI and Digital Tools to Support Daily QA Work
Digital Transformation – a journey
Use of GPT (Generative Pre-trained Transform) - (ChatGPT, MS Copilot)
Automated creation of documents/presentation
Translations / rewording of Texts
Use suggestions from Chat GPT, e.g. to define CAPA measures
Document analysis with GPT
Summarizing and extracting key information from multi-page reports (e.g. FDA 483s, guidelines)
Creation of meeting notes based on meeting transcripts and extraction of action items
ChatBots or user-defined GPT applications
Creation of GPT-ChatBots for Information search
Searching authorities’ sites to obtain Information
Search for references to audit observations specifically in the online versions of guidelines
Assistance on questions about process from process instructions, work instructions
Digitalization/Automation as the Basis for the Efficient Use of AI in QA and QC
Basics for QC & QA on IT framework - digitalization - automation - use of AI
Generation of raw data and data systems
Real-life automation examples QA & QC
Application Examples for AI in QA - from the Idea to Use
Collection and benefit assessment of AI use cases
Development of solutions
Automation Pipelines
No-code/low-code tools
Application examples in QA
Audit Management
Complaint Management
Deviation management
Quality management documentation
Digitalization/Automation and AI in QA
Application examples Batch release
Batch tracking & visualization
Authority documents
Cooperation between QA and production
GEMBA and GMP tours: automation example
Automation of Processes Using AI and Digital Tools
Microsoft Power Platform
Creation of applications and automations without in-depth programming Knowledge
Connection of AI elements with self-created applications and automations
Data Correctness – key for success
Automation of tracking and managing processes (Audit process as an example)
Using machine learning to automatically extract information from pdfs - Supplier Notification of Change (SNC) as example
GPT support for processing SNCs
Translation of documents transmitted in the respective national language
Support in the classification of SNCs in terms of criticality through AI recommendations
Use of GPT for the automatic generation of audit reports based on notes
Basics of Prompt Engineering
Introduction ChatGPT
Introduction to prompt engineering
Prompt techniques
Zero-shot prompting, few shot prompting
Chain-of-Thought
Reverse engineering prompting
Risks and misapplications
Use of AI in QC – Guidelines
QA processes and their specific needs
Step by step approach for automation/digitalization
Use-Cases of AI and Automation in QC
GPTs in QC for protocols, reports and qualification/validation documents
Investigation reports, stability protocols, qualification of equipment or standards, method validation, method transfer, responses to authorities
What are the basics of the use/application case?
KPI review and trend reports
From Data Generation to Use - Opportunities and Potential Pitfalls of Digitalization
Responsibility: Why data governance starts with the business process
System architecture: How we can make data usable and why one way is not always the right way
Data quality and integrity: Use of data in the GxP environment and how we can ensure trust in our data
Utilization: Systematic and sustainable implementation of digital tools, also through citizen development.digital tools, also through citizen development
Further Information
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.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts: Questions regarding content: Dr Gerhard Becker (Operations Director), +49 62 21 84 44-65, becker@concept-heidelberg.de Questions regarding organisation: Ms Manuela Luckhaupt (Organisation Manager), +49 62 21 84 44-66, luckhaupt@concept-heidelberg.de
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