Quality Requirements for Solids
Quality Requirements for Solids

Course Description

This 3-day online training is a deep dive into the world of solids. You will obtain detailed information about the manufacturing and quality characteristics and intensify your know-how about the complex regulatory landscape. This course will cover the area of API manufacturing, as well as of finished product manufacturing with many examples (e.g. capsules, tablets, suppositories). In break-out sessions and in many case studies we will discuss different GMP challenges together and we will focus on recent findings by the authorities. Another topic will be the switch to Continuous Manufacturing – what are the requirements and how can CM be realized?
  • Regulatory framework (EU-GMP Guideline, CFR, ICH guidelines e.g. Q9 and Q13, PIC/S, ISPE)
  • Quality & GMP requirements
  • Manufacturing challenges
  • Process validation
  • Pharma 4.0 and smart quality
  • Analytical methods
  • IPC requirements
  • Case studies for significant changes and follow-ups:
  • -- How to implement Continuous Manufacturing?
  • -- PAT for solid manufacturing areas
  • New breakout sessions during the course: You ask – the group discusses. Selected questions during the course will be discussed in the middle and at the end of each day to have an interactive course and to hear different opinions to a specific challenge
  • Understand the regulatory landscape
  • Overview over GMP and quality requirements for the manufacture
  • Pharma 4.0 for solid manufacturing
  • Challenges for the manufacturing of different solid medicinal products
  • Modern process validation concepts
  • How to implement effective and smart IPC concepts
  • Implementation of analytical methods for solids

Quality Requirements for Solids

12 - 14 June 2023, Live Online Training
€1.850,00
Dr. Felix Kern

Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.

Training dates will be announced soon. In meantime, feel free to request an agenda.

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Course Description

This 3-day online training is a deep dive into the world of solids. You will obtain detailed information about the manufacturing and quality characteristics and intensify your know-how about the complex regulatory landscape. This course will cover the area of API manufacturing, as well as of finished product manufacturing with many examples (e.g. capsules, tablets, suppositories). In break-out sessions and in many case studies we will discuss different GMP challenges together and we will focus on recent findings by the authorities. Another topic will be the switch to Continuous Manufacturing – what are the requirements and how can CM be realized?
  • Regulatory framework (EU-GMP Guideline, CFR, ICH guidelines e.g. Q9 and Q13, PIC/S, ISPE)
  • Quality & GMP requirements
  • Manufacturing challenges
  • Process validation
  • Pharma 4.0 and smart quality
  • Analytical methods
  • IPC requirements
  • Case studies for significant changes and follow-ups:
  • -- How to implement Continuous Manufacturing?
  • -- PAT for solid manufacturing areas
  • New breakout sessions during the course: You ask – the group discusses. Selected questions during the course will be discussed in the middle and at the end of each day to have an interactive course and to hear different opinions to a specific challenge
  • Understand the regulatory landscape
  • Overview over GMP and quality requirements for the manufacture
  • Pharma 4.0 for solid manufacturing
  • Challenges for the manufacturing of different solid medicinal products
  • Modern process validation concepts
  • How to implement effective and smart IPC concepts
  • Implementation of analytical methods for solids

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Quality Requirements for Solids

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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