Course Description

Stability data form an important element of pharmaceutical regulatory submissions. This 3-day course will equip participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. The course covers stability evaluations performed throughout the drug product life cycle, from product development to post-approval changes. Topics include fundamental chemical concepts, protocol design and the appropriateness of test methods for stability studies. The specific challenges posed by biological molecule stability are also covered. Each day includes a workshop session designed to reinforce key learning points.

Key Topics

Drug degradation chemistry
Regulatory guidance
Registration in different climatic zones
Stability chamber management
Design and validation of test procedures
Trending stability data – managing out-of-specification/out-of-trend results
Data integrity
Predictive stability
Stability testing for biologics
Impact of leachables on drug product stability

Learning Objectives

Key degradation mechanisms for drugs and biologics
Protocol design, including bracketing and matrixing
Establishing the suitability of analytical methods
Considerations for global registration
Justifying impurity limits
Handling temperature/humidity excursions and anomalous results
Designing stability studies to support post-approval change

Who should attend?

Past participants

Our online training experience includes

FAQ

Pharma & Biotech Stability Testing

17 - 19 October 2022, Live Online Training

€1.850,00

Unit price: per

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.

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

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Course Description

Stability data form an important element of pharmaceutical regulatory submissions. This 3-day course will equip participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. The course covers stability evaluations performed throughout the drug product life cycle, from product development to post-approval changes. Topics include fundamental chemical concepts, protocol design and the appropriateness of test methods for stability studies. The specific challenges posed by biological molecule stability are also covered. Each day includes a workshop session designed to reinforce key learning points.

Key Topics

Drug degradation chemistry
Regulatory guidance
Registration in different climatic zones
Stability chamber management
Design and validation of test procedures
Trending stability data – managing out-of-specification/out-of-trend results
Data integrity
Predictive stability
Stability testing for biologics
Impact of leachables on drug product stability

Learning Objectives

Key degradation mechanisms for drugs and biologics
Protocol design, including bracketing and matrixing
Establishing the suitability of analytical methods
Considerations for global registration
Justifying impurity limits
Handling temperature/humidity excursions and anomalous results
Designing stability studies to support post-approval change

Who should attend?

Past participants

Our online training experience includes

FAQ

"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