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Events 2020

• 11.-12.02.2020
  Mannheim: GMP-gerechter Prozess-Transfer
  In this conference, Dr. Hiltrud Horn will give detailed insight into regulatory strategies for the transfer of drug products in EU and US. You will learn how to handle process transfers efficiently ... More
  
• 18.02.2020
  Frankfurt: Nitrosamine Impurities
  In this conference you will get to know the relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances and drug products. Dr. Hiltrud Horn will ... More
  
• 19.03.2020
  Frankfurt: Nitrosamine Impurities
  Repetition of the seminar due to high demand. In this conference you will get to know the relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances ... More
  
• 21.-22.04.2020
  Heidelberg: Handling Changes and Variations
  In this two days conference, Dr. Hiltrud Horn will give presentations on how to deal with manufacturing process changes and with packaging changes. Furthermore, detailed insight will be provided on ... More
  
• 05.05.2020
  Live Online Seminar: Aktuelle Trends in der Qualitätskontrolle
  In this conference, Dr. Hiltrud Horn will focus on GMP compliance trends in analytical laboratories. In the first talk, she will update you on latest GMP-trends, explain you the implications of ... More
  
• 19.-20.05.2020
  Munich: Annex 2 & Co - GMP Compliance for Biopharmaceuticals
  In this two days conference, Dr. Hiltrud Horn will show you what is really important for the development of biotech products. You will learn how to deal with GMP and regulatory aspects. For more ... More
  
• 13.-14.07.2020
  Live Online Seminar: Der Regulatory Affairs Manager
  During this two days seminar, Dr. Hiltrud Horn will give detailed insight into the essentials of Regulatory Affairs. You will learn how to prepare the Quality part of the dossier and how to deal ... More
  
• 25.08.2020
  Frankfurt: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten
  In this training course, Dr. Hiltrud Horn will give detailed insight into the new concept of process validation and the essentials to be considered for the CTD. The latest dossier requirements on ... More
  
• 06.-07.10.2020
  Vienna: Change Control – New Aspects and Best Practices
  If you want to know how to handle changes in US and how to implement a comprehensive change control system within your company, then you should attend the “Change Control – New Aspects and Best ... More
  
• 08.-09.10.2020
  Vienna: ICH Q8 – Q11 Training Course
  In this two days conference, Dr. Hiltrud Horn will talk about the background and practical aspects of the QbD. You will understand the benefits and challenges of the QbD from practical examples. In ... More
  
• 13.-14.10.2020
  Hamburg: API Regulatory Starting Materials
  In this training course about the Regulatory Affairs Know-how of Active Pharmaceutical Ingredients (APIs), Dr. Hiltrud Horn will give detailed insight into the specifications and impurity of APIs ... More
  
• 20.-22.10.2020
  Berlin: Product Transfer - Organisation of GMP-compliant Site Change
  Dr. Hiltrud Horn will show how to develop a regulatory strategy for a site transfer covering EU and US. Furthermore Dr. Horn will present how to handle with additional unplanned changes during a ... More
  
• 29.-30.10.2020
  Vienna Drug Master File Procedures in the EU, the US and Japan
  In this two days conference, Dr. Hiltrud Horn will give detailed insight into the Drug Master File Procedures in the US. You will learn how to prepare the US-DMF and will get latest updates on ... More
  
• 04.-05.11.2020
  Hamburg: How to provide process validation data in regulatory submission
  Dr. Hiltrud Horn will provide the basics that CMC-people should know about process validation. You will get detailed insight into the traditional process validation and new concepts of continuous ... More
  
• 10.-12.11.2020
  Mannheim: Regulatory Compliance Expert - Arzneimittelzulassung für Mitarbeiter aus dem GMP-Umfeld
  In this conference, Dr. Hiltrud Horn will give detailed insight into typical CMC-issues that a CMC Manager or CMC-team leader should know. Apart from EU she will guide you through the registration ... More
  
• 02.-03.12.2020
  Prague: Setting Specifications and Acceptance Criteria
  Dr. Horn will explain strategies defining specifications for excipients and container closure systems in EU and US. Her presentation will cover the essential aspects for setting the right ... More
  
• 03.-04.12.2020
  Prague: Stability Testing for Drug Substances and Drug Products
  Dr. Hiltrud Horn will provide you with essential hints on how to write the stability section of the CTD for drug substances and drug products. Furthermore, she will talk about post-marketing ... More
  
• 08.-09.12.2020
  Prague: How to write the Quality Part of an IMPD
  In this two days conference, Dr. Hiltrud Horn will give detailed insight into the Quality Part of an IMPD. Her presentations on the first day will cover regulatory requirements and challenges of the ... More