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2-Day Course: Stability Testing of Pharmaceuticals (London, United Kingdom – July 3-4, 2019) – ResearchAndMarkets.com

May 3, 2019 Off By BusinessWire

DUBLIN–(BUSINESS WIRE)–The “Stability
Testing of Pharmaceuticals” conference has been added to ResearchAndMarkets.com’s
offering.

By attending this comprehensive two-day seminar delegates will learn how
to design efficient stability studies that are suitable for global
marketing, be able to carry out appropriate stability studies and manage
stability samples and facilities. Also know how to save resources on
stability testing and improve the likelihood of regulatory approval of
stability protocols.

Please note that this course will not cover particulars of the
stability of biopharmaceuticals.

Benefits in attending:

  • Gain knowledge on Storage Tests, Conditions and Protocols
  • 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

By attending this comprehensive two day seminar, delegates will:

  • Learn how to design efficient stability studies that are suitable for
    global marketing
  • Be able to carry out appropriate stability studies and manage
    stability samples and facilities
  • Know how to save resource on stability testing and improve the
    likelihood of regulatory approval of stability protocols

Who Should Attend?

Personnel involved in:

  • Stability testing of pharmaceutical products
  • 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

Agenda

Day 1 Schedule

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

Day 2 Schedule

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 https://www.researchandmarkets.com/r/bbw7rw

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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Related
Topics: Pharmaceutical
Manufacturing