Entry Level CMC - US edition MasterClass

09-10 May, 2023

The Entry Level CMC Masterclass covers the general requirements for small molecules and biologics.

Entry Level CMC - US edition MasterClass

Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.

 

09-10 May, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

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masterclass in pharma

Overview

 

Are ICH guidelines compulsory? What is the difference between analytical validation and analytical transfer? Do we need to test a compendial excipient? Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.
 

#masterclass     #glceurope      #pharma      #globalleadingconferences       #entrylevelCMC       #cmc

Who should attend imgRECOMMENDATION

Who should attend?


• Quality assurance specialists
• Regulatory Affairs CMC authors or reviewers
• Analytical and stability laboratory
• Project managers with CMC
• Chemistry, Manufacturing & Controls (CMC) regulatory
• Product scientists and test method technical experts (R&D and QC)
• Process analytical chemists and process development scientists

Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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10+

Years of experience

299

Events organized

3,410

Speakers

17,761

Attendees

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany