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Informa
Starting 3-11 November 2020

LIVE Online Academy - 5 Sessions

Learn to design a compliant pharmaceutical stability program you can apply in your workplace, overcoming common challenges

Book with earlybird pricing now!

Receive 20% off if you book before 27 October

Course Overview

Stability testing is a major requirement in the development of a pharmaceutical product to determine the versatility of a drug substance when exposed to certain conditions such as heat, pH, humidity, and radiation. It is vital for patient safety to know how a drug product will change over time and to provide adequate advice for the storage and disposal of the product. Stability failures are responsible for a third of product recalls, costing pharmaceutical companies millions. The risk of not conducting thorough stability testing, therefore, outweighs the cost of performing it.  
 
This course will provide you with an understanding of the science behind stability testing, a detailed examination of the ICH guidelines, and accurate assessments of the tools and techniques to carry out testing. Crucially you will gain a deeper understanding of the guidelines and how best to create stability protocols to maintain compliance.

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.

Over 5 sessions students will learn through:

  • Live interactive bitesize sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Chemistry Principles
Chemistry Principles

Understand the chemistry principles behind stability studies

Stability program design
Stability program design

Design a stability program compliant to ICH/FDA guidelines

Stability Data
Stability Data

Analyse stability data and derive your product shelf life


Matrixing and Bracketing
Matrixing and Bracketing

- Improve efficiency through matrixing and bracketing

GMP Requirements
GMP Requirements

Comply with current GMP requirements to avoid inspection failure

ICH
ICH

Interpret Q1A, Q1B and Q1E


FDA Inspection
FDA Inspection

Prepare for FDA inspection of your stability labs

Barr Decision
Barr Decision

Understand the Barr decision and thoroughly investigate OOS stability results

Who is this course for?

This course is highly recommended for anyone working in pharmaceuticals, in the following departments, fields or positions:

  • Stability
  • Analytical Chemistry/Methods
  • Formulation Development
  • QA/QC
  • Manufacturing/Production
  • Method Validation
  • Regulatory Affairs
  • GMP Compliance
  • Chemical Engineering
  • Development/Chemistry
  • Outsourcing
  • R&D Analyst / Assistant
  • Stability Officer / Supervisor / Analyst/ Coordinator
  • Analytical Development Engineer

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

Delegates of our live online academies said...

94%
would attend another live online academy
97%
found the course beneficial to their day to day role
97%
would recommend the course to others

RSC Approved Training

This course is approved by the Royal Society of Chemistry for the purpose of continuing professional development.

As the UK’s professional body for chemical scientists, the Royal Society of Chemistry supports professional development by listing excellent training opportunities on their database of approved courses. The approval process is one of peer review, involving assessment against set criteria by members that are expert in their field.