Your Experienced Keynote Speaker and Trainer for GMP Compliance
AboutStefan Mayer
Stefan Paul Mayer is an expert in the qualification of machinery and the validation and verification of pharmaceutical processes. He currently works for an innovative and renowned manufacturer of highly specialised machinery, where he leads the Sustainability & Compliance division. www.hoefliger.com
His training sessions on qualification and validation are offered by PTS Pharma Training Service and form part of a certification programme for Qualified Persons, with examinations conducted by Albstadt-Sigmaringen University of Applied Sciences.
In collaboration with the Ministry of the Environment of Baden-Württemberg, Stefan Paul Mayer has also presented as a speaker on the use of alternative energy systems to drive transformation, notably at the Liederhalle Stuttgart.
YourKeynoteSpeakerforCSR,OperationalCostReductionandSustainablePharmaceuticalProductDevelopment
Implementing Corporate Social Responsibility (CSR) in Germany
Topics Covered:
- The Path to Sustainable Business Operations
Target Audience:
- Primarily all companies classified as large under accounting law, as well as all legally small and medium-sized enterprises (SMEs) and third-country companies with significant turnover within the EU.
Intended Participants:
- Managers in Controlling and Supply Chain
- Compliance Officers
- Sustainability Managers
How to Successfully Achieve Climate Neutrality
Topics Covered:
- Examples of Integrating Alternative Energy Systems
- Examples of Process Optimisation
Target Audience:
- Relevant for all companies aiming to reduce their operational costs sustainably.
Intended Participants:
- Business Owners
- Building and Energy Managers
- Senior Technical Managers
- Sustainability Managers
Developing Sustainable Products for the Medical and Pharmaceutical Sectors – The Path Towards a Circular Economy
Topics Covered:
- The Role and Impact of Risk Assessments in the Approval Process
- Where Bioequivalence Is Truly Necessary
Target Audience:
- Relevant for all pharmaceutical companies looking to adapt their product development to a circular economy model.
Intended Participants:
- Heads of Product Development
- Regulatory Affairs Managers
- Development Engineers in Product Development
Trainer for GMP Qualification and Process Validation
Using comprehensive sample documentation, the complex content of the qualification phases for pharmaceutical equipment—followed by process validation or process verification—is conveyed in a structured and accessible manner.
Training on Qualification Documentation
Objectives:
- Gain a clear understanding of the qualification phases.
- Learn the structure of comprehensive documentation.
- Understand the connections between documentation and qualification.
- Use the sample documentation to replace or improve your own documents.
Final Examination:
- At the end of the intensive training, participants may choose to take an optional final examination. This additional qualification is recognised with a certificate upon successful completion.
Target Audience:
- Engineering and Technical Teams
- Qualification Teams
- GMP Compliance Monitoring
- Quality Units
- External Service Providers
Key Features:
- Presentation of a practical, inspection-tested documentation system for qualification
- Forms are systematically designed with a consistent structure.
- User requirement specifications and functional specifications are provided as checklists with self-explanatory questions and are aligned with each other.
Industries:
- Pharmaceutical Industry
- Active Pharmaceutical Ingredient (API) Manufacturing
- Medical Device Manufacturing (with GMP requirements)
- Suppliers and Service Providers
Training on Validation Documentation
Objectives:
- Learn the structure of comprehensive documentation and understand the link between documentation, process validation, and process verification.
- Gain practical insights into the content of process validation.
- Use the sample documentation to replace and improve your own documents.
Final Examination:
- At the end of the intensive training, participants may choose to take an optional final examination. This additional qualification is recognised with a certificate upon successful completion.
Target Audience:
- Engineering and Technical Teams
- Validation and Qualification Teams
- GMP Compliance Monitoring
- Quality Units
- External Service Providers
Key Features:
- Qualification as a Validation Manager: By completing both modules, you gain the qualification as a Validation Manager. An additional certificate can be issued upon request.
- Benefit from meticulously prepared documentation.
- Receive extensive sample documents as ready-to-use templates.
- Take advantage of the clear, user-friendly document structure.
- Get an overview of the latest developments in process validation and process verification.
- Learn the latest terminology.
Industries:
- Pharmaceutical Industry
- Active Pharmaceutical Ingredient (API) Manufacturing
- Medical Device Manufacturing (with GMP requirements)
- Suppliers and Service Providers
BookYourGMPComplianceLectureorGMPTrainingNow.
Enquire NowFrequentlyAskedQuestions
What is GMP?
GMP (“Good Manufacturing Practice”) refers to the set of regulations governing the proper manufacture of medicines, ensuring uncompromising quality standards during the production, processing, packaging, and storage of pharmaceutical products.
Who must comply with GMP guidelines?
To ensure that patients can rely on consistently high-quality medicines, manufacturers of medicinal products and active pharmaceutical ingredients must adhere to GMP guidelines throughout production, processing, testing, packaging, and storage.
What are the five main components of GMP?
The five key elements of GMP are People, Premises, Processes, Products, and Procedures. These essential components should always be considered when implementing effective GMP policies in your organisation.
How long does a keynote lecture last?
Keynote lectures are designed to fit within a timeframe of approximately 45 to 60 minutes, including a Q&A session at the end.
Do you offer keynote lectures in English?
Keynote lectures in English are currently being developed and will be available soon.
Do you offer in-house training?
In-house training is available for all listed subject areas. For process optimisation and sustainability topics, training can be booked directly through MAYKON Solutions. Training on qualification and validation topics is organised by PTS Pharma Training Service on our behalf.
How long does a training session last?
Depending on the topic, training sessions typically last 1 to 2 days.