2024-06-12 2024-06-12 , online online, 1,190 € plus tax Dr. Ralf Aubeck https://www.forum-institut.com/seminar/24102463-mastering-fda-inspections-preparation-and-best-practices/referenten/24/24_10/24102463-seminar-mastering-fda-inspections-preparation-best-practices_aubeck-ralf.jpg Mastering FDA inspections: Preparation and Best Practices

FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

Topics
  • Key regulatory requirements
  • How to prepare in advance?
  • Special considerations in FDA inspections
  • Follow-up: What you need to pay attention to
  • Avoiding FDA 483s, handling 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 - Mastering FDA inspections: Preparation & Best Practices

Mastering FDA inspections:
Preparation and Best Practices

- Online training -

Benefits
  • Insights into FDA inspections
  • Identifying critical compliance areas
  • Effective preparation strategies
  • Avoiding 483s, handling warning letters
  • Officially certified according to ISO 9001 + 21001

Webcode 24102463

Book now

JETZT Buchen

Speaker


Everything at a glance

Appointment

15/10/2024

15/10/2024

Period

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
Venue

online

online

Fee
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

Topics

  • Key regulatory requirements
  • How to prepare in advance?
  • Special considerations in FDA inspections
  • Follow-up: What you need to pay attention to
  • Avoiding FDA 483s, handling 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

09:00 Welcome, expectations, introduction round


09:15

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

10:15

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?

13:00

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

14:15

Workshop/practical activity
  • How to read the content of an US FDA 483
  • How to establish a defense strategy

This practical session includes a flexible bio break of 10-15 minutes.

15:00

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

16:00

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

16:30 Questions, sharing of experiences and discussion


17:00 End of the event


More information

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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.

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  • High level of interactivity with plenty of opportunity for questions
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  • Free technical pre-meeting to start off your training on the right foot

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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.

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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.

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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.

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