2024-02-28 2024-02-28 , online online, 1,190 € zzgl. MwSt. Dr. Ralf Aubeck https://www.forum-institut.de/seminar/24032460-fda-inspection-readiness/referenten/24/24_03/24032460-seminar-pharma-fda-inspection-readiness_aubeck-ralf.jpg FDA inspection readiness

LAST CALL! - CANCELLATION DEADLINE: 28.02.2024 - FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

Topics
  • Regulatory landscape: General framework
  • How to prepare in advance?
  • Challenges to manage during FDA inspections
  • Follow-up: What you need to pay attention to
  • Dealing with FDA 483s and warning letters


Who should attend
This seminar suits the needs of pharmaceutical industry professionals, who have to deal with the preparation and management of an FDA inspection.

In particular, participation will benefit:
  • Managers of Regulatory Affairs and Quality Assurance; as well as
  • Regulatory Affairs professionals that submit INDs, NDAs, BLAs, and ANDAs.
Aims and objectives
Your desire for the next FDA inspection: The list of deficiencies remains small because your company is "inspection-ready" prior to it?!

This seminar aims to provide you with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical facilities. It will also cover the FDA’s approach to inspections, focus areas, and the documents they will be asking for.

By the end of the seminar, you will have learned how to manage inspections efficiently and effectively, and how to present information about your quality system in the most competent and professional manner.
Your benefit

Benefits you can expect from attending this seminar: - Gain an understanding of the parameters, approaches, and concerns of FDA inspectors. - Learn how to prepare, cope, and manage FDA inspections in pharmaceutical facilities. - Understand the FDA’s approach to inspections, focus areas, and the documents they will be asking for. - Learn how to manage inspections efficiently and effectively.

Seminar Pharma - FDA inspection readiness

FDA inspection readiness:
Best practice for a smooth inspection

LAST CALL! - CANCELLATION DEADLINE: 28.02.2024 -

Benefits
  • First-hand information
  • Practical know-how
  • Manage FDA inspections with confidence and eas
  • Submit your questions prior to the training
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24032460

Jetzt buchen

JETZT Buchen

Referent


Alles auf einen Blick

Termin

14/03/2024

14/03/2024

Zeitraum

09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

LAST CALL! - CANCELLATION DEADLINE: 28.02.2024 - FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

Topics

  • Regulatory landscape: General framework
  • How to prepare in advance?
  • Challenges to manage during FDA inspections
  • Follow-up: What you need to pay attention to
  • Dealing with FDA 483s and warning letters


Who should attend
This seminar suits the needs of pharmaceutical industry professionals, who have to deal with the preparation and management of an FDA inspection.

In particular, participation will benefit:
  • Managers of Regulatory Affairs and Quality Assurance; as well as
  • Regulatory Affairs professionals that submit INDs, NDAs, BLAs, and ANDAs.

Aims and objectives

Your desire for the next FDA inspection: The list of deficiencies remains small because your company is "inspection-ready" prior to it?!

This seminar aims to provide you with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical facilities. It will also cover the FDA’s approach to inspections, focus areas, and the documents they will be asking for.

By the end of the seminar, you will have learned how to manage inspections efficiently and effectively, and how to present information about your quality system in the most competent and professional manner.

Your benefit

Benefits you can expect from attending this seminar: - Gain an understanding of the parameters, approaches, and concerns of FDA inspectors. - Learn how to prepare, cope, and manage FDA inspections in pharmaceutical facilities. - Understand the FDA’s approach to inspections, focus areas, and the documents they will be asking for. - Learn how to manage inspections efficiently and effectively.

Detailed programme

09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

Regulatory landscape: General framework
  • Role, duties, responsibilities of the US FDA
  • The FDA's approach to inspections - what is special?
  • Regulatory requirements
  • Inspector means Investigator

How to prepare in advance?
  • How to prepare in the most efficient and effective way?
  • What documents will inspectors ask for?
  • How to identify critical compliance areas?
  • How to avoid 483s and increased enforcement actions?
  • How to avoid warning letters?
  • How to prepare for an Pre-Approval-Inspection (PAI)-?
  • How to do technical writing of GMP documents?
  • How not to forget the hot topics?

Challenges to manage during FDA inspections
  • Cultural details/differences between EU and USA
  • Behavior during inspection: Dos and Don'ts
  • How to to prepare information for FDA investigators
  • How to manage "hot topics"
  • Presenting the Quality System in the most professional way

Workshop/practical activity
  • How to read the content of an US FDA 483
  • How to establish a defense strategyThis practical session includes a flexible bio break of 10-15 minutes.

Follow-up: What you need to pay attention to
  • Sustainable dokumentation
  • Robust company inspection process
  • Lessons learned
  • "Verbal" recommendations

Dealing with FDA 483s and warning letters
  • Is it "normal" to receive an FDA 483?
  • Practical examples
  • Approaches to give an adequate response
  • How to trigger a Warning letter and how to avoid it

Questions, sharing of experiences and discussion


More information

LAST CALL! - CANCELLATION DEADLINE: 28.02.2024 -

Please note the stated cancellation period.
If you are interested at short notice, please contact me directly: b.wessels@forum-institut.de or 06221 - 500 652.

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

In-house seminars: Advanced training tailor-made!

You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!

We also offer this seminar as an in-house seminar.

Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.

We will be happy to send you a non-binding offer.

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

This distinguishes our events

Overall score of all evaluations in 2023

Five stars on Trustpilot = Excellent

Recommendations

All about ATMP

The online seminar with details on development, quality, CMC, approval and market access for advanced therapy medicinal ...

14. - 15.03.2024, Online
Details
Corrective And Preventive Actions (CAPAs) in der Pharmakovigilanz

Fehler und Abweichungen rechtzeitig zu erkennen und entgegenzuwirken, ist das A und O in der Arzneimittelsicherheit. Erf...

04.03.2024, Online
Details

Pharmacovigilance Inspection Readiness

Discover the cutting-edge landscape of (remote) pharmacovigilance inspection strategy in Europe through our dynamic onli...

22.04.2024, Online
Details

Großhandelsbeauftragte

Ein Seminar über die verantwortlichen Personen von pharmazeutischen Unternehmen und des Großhandels - die Aufgaben, Vera...

13.03.2024, Online
Details

Die Fachassistenz im Pharma-Unternehmen

In dieser Webcast-Serie erhalten Sie essenzielles Grundlagenwissen zu den Aufgaben, Verantwortlichkeiten und den Bereich...

09.04. - 28.06.2024, Online
Details

Go forward

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses.

Details
Our international course portfolio
e-Learning - Click and learn

We provide flexible education and training with high-quality e-Learning programmes for several topics.

Details
e-Learning
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

Details
We guarantee the highest quality