2024-09-19 2024-09-19 , online online, 1,190 € zzgl. MwSt. Mastering FDA inspections: Preparation and Best Practices

LAST CALL! - REGISTRATION DEADLINE: 15.10.2024 - FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

Themen
  • 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.
Ziel der Veranstaltung
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.
Teilnehmerkreis

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

LAST CALL! - REGISTRATION DEADLINE: 15.10.2024 -

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

Jetzt buchen

JETZT Buchen

Alles auf einen Blick

Termin

15/10/2024

15/10/2024

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

Downloads
PROSPEKT
PROSPEKT
Gebühr

Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes the documentation for download, a certificate, access to the Learning Space, and technical support including pre-meeting.

Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes the documentation for download, a certificate, access to the Learning Space, and technical support including pre-meeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

LAST CALL! - REGISTRATION DEADLINE: 15.10.2024 - FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

Themen

  • 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.

Ziel der Veranstaltung

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.

Teilnehmerkreis

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.