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.
The primary purpose of this course is to review the various properties of powdered solids in relation to development and manufacture of pharmaceutical products. Covered topics include:
- Analytical techniques for determination of:
Particle size distribution
Specific surface area
- Regulatory requirements for powder characterisation
- Development of analytical methods for powder characterisation
- Validation of analytical methods for powder characterization
- Linking material properties to formulation/processing behaviour, stability and bioavailability.
- Identifying potential Critical Product Attributes related to the drug substance: Real life examples
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.
26th March 2020 in Milan, Italy.
Pre-registration for this event is now open. To register, please send an e-mail to email@example.com, 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.