Two Day Stability Testing of Pharmaceuticals Seminar - London, United Kingdom - December 6th-7th, 2016 - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Stability Testing of Pharmaceuticals" conference to their offering.

Benefits in Attending:

- Gain knowledge on Storage Tests, Conditions and Protocols and Learn how to design Protocols for global marketing

- Discover how to manage Stability Samples and Facilities

- Develop robust Stability Indicating Methods

- Comply with Stability requirements for existing products and line extensions

- Understand what Stability Testing is required following changes to a product

- Discuss data treatment, shelf life assignment and extrapolation

Agenda

Programme Day One

09.30 Delegate introductions

09.45 Background to Stability Testing and Guidelines

- The rationale for stability testing

- Relevant guidelines

10.45 Refreshments

11.00 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

11.50 Exercise one

12.10 Lunch

13.20 Developing Robust, Stability Indicating Methods

- Producing impurities

- Guidance on stress testing

- Producing potential impurities of synthesis

- Producing potential impurities of degradation

- Choosing columns and mobile phases • Identifying important method parameters

- Optimising method parameters • Ensuring the method is robust

14.30 Stability Requirements for Existing Products and Line Extensions

- Guidelines available

- Requirements for active ingredients

- Requirements for product

- Requirements for variations to marketed products

15.15 Refreshments

15.35 Exercise two

- Designing a more complex stability protocol

Management of Stability Samples

- Sample management

- Validation of storage facilities

- Ongoing validation

- How to treat excursions from condition

17.00 Close of day one

Programme Day Two

09.00 Developing robust, stability indicating methods

- Producing impurities

- Guidance on stress testing

- Producing potential impurities of synthesis

- Producing potential impurities of degradation

- Choosing columns and mobile phases

- Identifying important method parameters

- Optimising method parameters

- Ensuring the method is robust

Data Treatment, Shelf Life Assignment and Extrapolation

- When is statistical treatment required?

- How much extrapolation beyond real time data is allowable?

- OOS/OOT results

10.30 Refreshments

10.45 Exercise three – Data Treatment

11.45 Light stability testing

- ICH Q1B Guidelines

- Light sources

- Required exposure

- Problems in light testing

12.15 Packaging considerations

- Guidelines

- Requirements when changing packaging

- Demonstrating equivalence

- Interaction studies

12.45 Lunch

13.45 Sundry considerations

- Bulk stability

- Pharmaceuticals manufactured in Zones III and IV for sale in Zone II

- How to be inspection ready

- Accelerated Stability Assessment Testing (ASAP)

14.15 Matrixing and bracketing stability studies

- Bracketing designs

- Matrixing designs

- ICH Q1D guidelines

- What is acceptable for bracketing and matrixing

15.30 Refreshments

15.45 Exercise four

*Designing efficient stability protocols

16.45 Closing questions and discussion

17.00 Close of forum

For more information about this conference visit http://www.researchandmarkets.com/research/sc2dbp/stability_testing

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceuticals

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceuticals