e-Learning: GDP - Basic Training
Basic training to understand the requirements of GDP in today's pharmaceutical industry
- Flexibility in location and timing
- You establish your own learning speed
- Tests and feedback
- Officially certified to ISO 9001 and ISO 21001 standard.
Buchungsdetails
This e-Learning programme will provide you with knowledge on Good Distribution Practice in today's pharmaceutical industry
Your speaker
Dr. Stefan Lakonig
Haecon GmbH
Dr Stefan Lakonig is an experienced GxP auditor and consultant with extensive international expertise in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and quality…
Your speaker
Dr. Stefan Lakonig
Haecon GmbH
Dr Stefan Lakonig is an experienced GxP auditor and consultant with extensive international expertise in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and quality management systems for the pharmaceutical industry. As the former Deputy Head of Quality Assurance at a German active pharmaceutical ingredient manufacturer, he gained expertise in quality assurance. He currently serves as a lead GMP and GDP auditor for third-party audits at Haecon GmbH.
Since 2006, he has been an auditor and consultant on various GxP projects in manufacturing and research. His assignments have taken him across Europe, Turkey, China, India, Myanmar, Korea and Israel. He draws on a wealth of experience gained from successfully conducting more than 300 audits.
What to Expect
- Defining GDP
- From regulations to implementation: quality management
- Key roles in the GDP environment
- GDP in practice: storage, incoming goods, picking and transport
- Qualification and validation
- Complaints, returns, suspicion of counterfeit drugs, drug recalls
- Life cycle supplier management
- GDP audits
Who Should Attend
Are you starting your role in GDP at a pharmaceutical company, a transport or storage service provider, or a wholesaler? Or are you working in another department that has touchpoints with GDP? This e-learning course offers a quick and effective way to learn the essentials of Good Distribution Practice and also serves as a refresher.
Objective of the Event
The EU Guideline "Guideline for Good Distribution Practice for Medicinal Products for Human Use" stipulates that all employees involved in wholesale activities must be trained in the requirements of Good Distribution Practice (GDP). They should possess the necessary competence and experience before commencing their duties.
This e-learning course provides you with the fundamental principles of Good Distribution Practice for medicinal products for human use. Step by step, our experienced speaker guides you through the current regulatory framework and its implementation, explaining key definitions, tasks, and responsibilities.
All essential concepts are presented clearly and comprehensibly, illustrated through practical examples and interactive tools. Learning assessments after each module allow you to track your progress at any time and present it during audits and inspections.
Are you the responsible person for pharmaceutical wholesale in your company? With our e-Learning course - designed for participants without prior technical knowledge - you can train your (new) employees anytime in a compact and time-efficient manner!
Your Benefit
- Become proficient in all essential aspects of GDP in just 3.5 hours
- Integrated multiple-choice tests to check effectiveness and issue a certificate of completion
- Ideal for documentation to be provided during inspections and audits
- Special discounts for multiple participants from the same company
Programme
Dr. Stefan Lakonig
- Defining GDP
- GDP for active ingredients and pharmaceuticals
- Supply chain integrity
- The regulatory environment in Europe
- Boundaries between GMP and GDP
Dr. Stefan Lakonig
- Wholesale representative
- GDP responsible person
- Qualified person
- Differences and intersections
Dr. Stefan Lakonig
- Quality management principles
- Quality management in GDP
- Components of a quality management system in GDP
Dr. Stefan Lakonig
- Pharmaceutical storage: premises, environment and risk management
- Incoming goods: verification, condition check and storage requirements
- Picking process: from order receipt to dispatch
- Ensuring safe transport: temperature control, route planning, documentation and more
- Transport management systems
Dr. Stefan Lakonig
- Risk management for GDP
- Key elements of storage facilities
- Temperature mapping studies: how to install a GDP-compliant monitoring system
- Qualification of equipment (trailers)
- Verification of transport routes
Dr. Stefan Lakonig
- Managing complaints: recording, investigating and resolving issues
- Returns: six steps to assess the quality of returned goods
- Suspicion of counterfeit drugs: things to do
- Reasons for drug recalls and how to set up the process
Dr. Stefan Lakonig
- Qualification of suppliers
- Contracts and written agreements
- Types of audits: on-site, remote and third-party audits
- Typical audit focal points
- Common errors and deficiencies
Module 1:
Basics: What is GDP?
Module 1: Basics: What is GDP?
Dr. Stefan Lakonig
- Defining GDP
- GDP for active ingredients and pharmaceuticals
- Supply chain integrity
- The regulatory environment in Europe
- Boundaries between GMP and GDP
Module 2:
Key roles in GDP: Who does what?
Module 2: Key roles in GDP: Who does what?
Dr. Stefan Lakonig
- Wholesale representative
- GDP responsible person
- Qualified person
- Differences and intersections
Module 3:
GDP - from regulations to implementation
Module 3: GDP - from regulations to implementation
Dr. Stefan Lakonig
- Quality management principles
- Quality management in GDP
- Components of a quality management system in GDP
Module 4:
GDP in practice
Module 4: GDP in practice
Dr. Stefan Lakonig
- Pharmaceutical storage: premises, environment and risk management
- Incoming goods: verification, condition check and storage requirements
- Picking process: from order receipt to dispatch
- Ensuring safe transport: temperature control, route planning, documentation and more
- Transport management systems
Module 5:
Qualification and validation
Module 5: Qualification and validation
Dr. Stefan Lakonig
- Risk management for GDP
- Key elements of storage facilities
- Temperature mapping studies: how to install a GDP-compliant monitoring system
- Qualification of equipment (trailers)
- Verification of transport routes
Module 6:
Special situations
Module 6: Special situations
Dr. Stefan Lakonig
- Managing complaints: recording, investigating and resolving issues
- Returns: six steps to assess the quality of returned goods
- Suspicion of counterfeit drugs: things to do
- Reasons for drug recalls and how to set up the process
Module 7:
Life cycle supplier management
Module 7: Life cycle supplier management
Dr. Stefan Lakonig
- Qualification of suppliers
- Contracts and written agreements
- Types of audits: on-site, remote and third-party audits
- Typical audit focal points
- Common errors and deficiencies
Workshops
GDP - Basic training
Here you can get a brief insight into our e-learning GDP-Baisc training.
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Downloads
brochure
All details and content at a glance.
Weitere Informationen
Content
The e-learning programme 'GDP - Basic training' comprises seven didactic modules that include videos, exemples an interaktive tools in which the expert Dr. Stefan Lakonig shares his expertise with you. You can also download and print the corresponding presentation documents.
Some modules comprise additional documents (links, guideline texts, etc.), which help you practise and apply your newly gained knowledge.
Once you have completed the seven modules and passed a final multiple-choice test,
you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment: www.forum-institut.com/demo-account
How does it work?
1. Register for an e-learning programme on our website.
2. You will receive an email with your login data for our learning platform.
3. Log in to start your e-learning programme.
4. Complete your e-learning modules at your own pace.
5. Finalise the modules with a multiple-choice test.
6. Once you have successfully completed the test, you will be awarded a certificate, which you can print out.
Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.
Package options
We offer attractive package options - feel free to contact us if you’d like to train several employees or require a flexible annual quota.
Would you like to host the e-Learning on your company’s internal platform? That’s no problem! Our e-Learnings are also available as SCORM files, which can be seamlessly integrated into your internal learning platform. Get a personalised quote today.
Contact us by email at service@forum-institut.de.
Our Recommendations
GDP-Manager
Wählen Sie Ihre GDP-Trainingsschwerpunkte aus einem Portfolio von mehr als 20 Webcastsserien!Sprache: Deutsch
e-Learning: Basiswissen GDP für Einsteiger*innen
Mit unserem speziell auf Einsteiger*innen zugeschnittenen E-Learning erfassen Sie spielend die Grundlagen der Good Distribution Practice - essentiell für alle Mitarbeiter*innen! Ihr Vorteil:…Sprache: Deutsch
GDP-Manager ADVANCED
Wählen Sie Ihre GDP-Trainingsschwerpunkte aus einem Portfolio von mehr als 20 Webcastsserien!Sprache: Deutsch
Further Information
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
DEMO-Account e-Learning
Try out our e-Learning programmes free of charge and without any obligation.
Our rating in 2024
More than 4000 customers have rated our training courses. Thank you for awarding us 4.3 stars out of 5.
Your Contact Person
We are happy to advise you personally and individually.
Dr. C. Michaela Gottwald
Konferenzmanagerin Pharma & Healthcare
+49 6221 500-610
m.gottwald@forum-institut.de