Pharma_and_Biotech_Stability_Testing
Pharma_and_Biotech_Stability_Testing

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.
  • 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

Pharma & Biotech Stability Testing

17 - 19 October 2022, Live Online Training
Regular price €1.850,00
Unit price
per 
Dr Mark Powell

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.

Need help? Contact us

100% Secure payments

Your details are protected and safe with us. Taxes calculated at the checkout.

American Express
Apple Pay
Mastercard
Visa

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.
  • 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

"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

Pharma & Biotech Stability Testing

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

In-house Training

Looking for tailored training solution?

All of our pharma & biotech training courses can be delivered at your company premises at a time that suits you. If you can not find what you are looking for in our public training offering, our trainers and producers will develop bespoke programmes to address your training needs.