Free 1-day course on physical characterization of pharmaceutical materials

About us

Particle Analytical is a GMP-certified and FDA registered contract laboratory with 20 years experience in physical characterization of pharmaceutical products. Based on our 20 years experience, we offer this 1-day course, free of charge, to share knowledge with professionals in the pharmaceutical industry.

Background for the course

By far, the most important physical property of particulate samples is particle size. Particle size determinations are routinely carried out across a wide range of industries and is a critical parameter in the manufacture of pharmaceutical products. Particle size has a direct influence on material properties such as reactivity, dissolution rate, stability, flowability and handling.

Particle size distribution should be known – and controlled! Ultimately, to protect patients, but also to avoid unpleasant surprises during manufacture. Measurement of particle size is not an exact technique and a “true” value does not exist. A range of analytical techniques are available for determination of particle size; these all have their strengths and weaknesses. In order to develop and validate analytical methods for determination of particle size, it is necessary to correlate several methods.

Other important properties for control of your drug product includes crystal structure and specific surface area (SSA). Control of these properties are relevant from formulation to marked release, and capacities and limitations of relevant analytical techniques are therefore important to understand.

In this course we will give you an overview of methods and regulatory requirements and based on real life examples, we will go through commonly observed pitfalls that should avoided.

Program for the 1-day course on physical characteriaztion of pharmaceutical products:

Session 1: Why is it important?
– Technical aspect
– Regulatory aspect

Session 2: How is physical characterization performed?
– Particle size
– Surface area
– Crystal structure

LUNCH

Session 3: Product customized methods – Why are they needed?
– General introduction
– Particle size
– Surface area
– Crystal structure

Session 4: Product customized methods – How are they developed?
– Choosing the right analytical technique
– Developing the method
– Technical constraints

Session 5: Product customized methods – Regulations
– Method development
– Method transfer
– Method validation

Recommended audience

This course is intended for all professionals involved with physical characterization of pharmaceutical products, including:

  • Scientists: Underlying principles of analytical methods – Strengths and weaknesses
  • Technologists: Introduction to analytical methods and commonly observed industrial problems
  • Regulatory and quality personnel: Understanding the development process.
Time and place

This 1-day course will be held in two different locations:

24th March 2020 in Frankfurt, Germany.

Unfortunately we have had to postpone this course due the situation with COVID-19. We will set a new date for the course as soon as the situation is returning to normal

26th March 2020 in Milan, Italy.

Unfortunately we have had to postpone this course due the situation with COVID-19. We will set a new date for the course as soon as the situation is returning to normal.

Registration

Registration for this event is now open. To register, please send an e-mail to sales@particle.dk, stating your name, company name, your position and the country where you wish to participate in the event (i.e. either Italy or Germany)
An e-mail with the final details of the course will be send on the 29th of February 2020
Participation in this course is FREE OF CHARGE.