Quality Requirements for Solids

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

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

KEY TOPICS

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

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