Stability Testing of Pharmaceuticals (London, United Kingdom - December 4-5, 2018)

  • ID: 4523028
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: December 4-5, 2018
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Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learning how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

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

Benefits in Attending:

  • Gain knowledge on Storage Tests, Conditions and Protocols n 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

Why You Should Attend

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


* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
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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

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  • Ray Munden Dr Ray Munden,
    Head of Analytical Services Europe ,
    GlaxoSmithKline


    Dr Raymond Munden has over 30 years’ experience in pharmaceutical research and development and was formerly Head of Analytical Services Europe for GlaxoSmithKline.

    He has led project teams that developed many new chemical entities and their pharmaceutical products that were successfully taken to market.

    He has particular expertise in stability protocol design and testing, stability storage facilities, experimental design and degradation chemistry. He is now a consultant for all aspects of pharmaceutical development.

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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
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ADDRESS

The Rembrandt Hotel
11 Thurloe Place
London
SW7 2RS
United Kingdom


DIRECTIONS

Opposite V&A Museum.
Nearest underground station: South Kensington.

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