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Events 2021
09.-10.02.2021
Live Online Seminar: 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 ...
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16.-17.03.2021
Live Online Training: 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 ...
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14.-15.04.21
Live Online Training: 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 ...
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20.-21.04.2021
Vienna: 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 ...
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06.-07.10.2021
Hamburg: 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 ...
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03.-04.11.20021
Berlin: 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 ...
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Events
09.-10.02.2021
Live Online Seminar: GMP-gerechter Prozess-Transfer
More
16.-17.03.2021
Live Online Training: Annex 2 & Co - GMP Compliance for Biopharmaceuticals
More
14.-15.04.21
Live Online Training: Handling Changes and Variations
More
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News
29.10.2020
Latest Guidances regarding Nitrosamine Impurities
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18.05.2020
Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
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26.03.2020
New Deadline for Nitrosamine Impurities
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