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
press@researchandmarkets.com
For
E.S.T Office Hours Call 1-917-300-0470
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1-800-526-8630
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Related
Topics: Pharmaceutical
Manufacturing