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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

11-12 July 2024
+ 11-12 November 2024 »
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

By attending this intensive two-day seminar, delegates will learn how to:

Carry out appropriate stability studies and manage stability samples and facilities
Design stability studies that are suitable for global marketing
Increase the likelihood of studies receiving regulatory approval
Save resources on stability testing with potential large financial savings

A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.

Please note that we are delighted to confirm that this course will now also include particulars of the stability of biopharmaceuticals.

Benefits of attending:

Comply with stability requirements for new and existing drug substances, products and line extensions
Gain knowledge on storage tests, conditions and protocols
Learn how to design highly efficient protocols for global marketing with potentially large financial savings
Discover how to manage stability samples and facilities
Understand what stability testing is required following changes to a product
Discuss data treatment, shelf-life assignment and extrapolation

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Who should attend?

Personnel involved in:

Stability testing of pharmaceuticals and biopharmaceuticals
The design of stability protocols
The management of stability samples and facilities
The development of pharmaceuticals which require stability testing
The production of regulatory documents which include stability data
Quality assurance

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This course will cover:

Day 1
Day 2

Background to stability testing and guidelines

The rationale for stability testing
Relevant guidelines

Storage tests, conditions and protocols

Tests for drug substance and product types
Storage conditions and periods required
Typical protocols
Developing global stability protocols
In-use testing

Exercise 1: Designing a simple stability protocol

Management of stability samples and facilities

Sample management
Validation of storage facilities
How to treat excursions from condition

Requirements for existing products, line extensions and variations

Guidelines available (ICH, EU and USA)
Requirements for active ingredient
Requirements for product
Requirements for variations to marketed products

Exercise 2: Designing a more complex stability protocol

Data treatment, shelf-life assignment and extrapolation

When is statistical treatment required?
How much extrapolation beyond real-time data is allowable?
Presentation of data in submissions
Setting shelf-life specifications

Exercise 3: Data treatment

Light stability testing

ICH Q1B guidelines
Light sources
Required exposure
Problems in light testing

Packaging considerations

Guidelines
Requirements when changing packaging
Demonstrating equivalence
Permeation considerations
Interaction studies

Exercise 4: Packaging

Biopharmaceutical stability

ICH Q5C and regulatory guidance
Complexity associated with biopharmaceuticals
Stability-indicating assays for biopharmaceuticals
Stability considerations for new modalities

Sundry considerations

Bulk stability
Manufacture in zones III/IV to be sold in zone I
Out-of-specification in stability

Matrixing and bracketing stability studies

Bracketing designs
Matrixing designs
ICH Q1D guidelines
What is acceptable for bracketing and matrixing?

Exercise 5: Designing efficient stability protocols

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Paul Palmer
Paul R Palmer Ltd

Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.

Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.

People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.

Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.

More details

Farah Nadeem
Paul R. Palmer Limited

Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.

Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.

In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.

More details

Farah Nadeem
Paul R. Palmer Limited

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

11-12 July 2024

Live online

09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 13808

GBP 1,299
EUR 1,869
USD 2,129

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

11-12 November 2024

Live online

09:30-17:15 UK (London) (UTC+00)
10:30-18:15 Paris (UTC+01)
04:30-12:15 New York (UTC-05)
Course code 14037

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 07 Oct

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.