DAY 1 : (9 AM – 5 PM)
Registration: 8.30 AM – 9 AM
- Overview of ICH Q8 (Pharmaceutical Development)
- The biopharmaceutics classification system and drug pharmacokinetics
- Roles and responsibilities within the pharmaceutical development team
- Commercial and regulatory considerations
- Drug master files
- Excipient quality considerations
- Drug product specifications
- Compliance with regulatory expectations in relation to elemental impurities and residual solvents
- Quality target product profile, critical quality attributes and control strategy
- Managing risk in pharmaceutical development
- Regulatory submissions: the Common Technical Document
2. Analytical methods:
- Performance requirements of analytical methods
- Attributes of stability-indicating assay and impurities methods
- The dissolution method
- Discriminating potential
- Regulatory expectations for immediate, delayed and extended-release products
- Uniformity of dosage units
- Moisture: significance and measurement
- Assay methods for preservatives and anti-oxidants
- Microbiological methods and specifications
- Polymorphic and enantiomeric stability
- Phase-appropriate method validation
- Life-cycle management of analytical methods (ICH Q14)
Q&A and Networking: 4.30 PM – 5 PM
DAY 2 : (9 AM – 5 PM)
1. Formulation/process development:
- Chemical compatibility
- Blending and granulation
- Compression and the effect of material properties
- Measuring the physical properties of tablets
- Capsule properties
- Scale-up and registration batch manufacture
- Process validation
2. Drug product stability evaluation:
- Choice of primary pack (protection against moisture, oxygen and light)
- Early stage
- Drug product stress studies
- Prototype/feasibility stability
- Late stage
- Registration batch stability
- Temperature cycling and bulk hold studies
- In-use stability for multi-dose packs
- Clinical studies
- Biowaiver conditions (including new draft ICH guidance)
Q&A, Certification, Networking and Close: 4.30 PM – 5 PM
Dr. Mark Powell
Dr. Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.
He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.
|Number of delegates||Discount|
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Regular Price – Rs 29000 + GST
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EARLY BIRD OFFERS CLOSES ON NOVEMBER 25, 2019
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