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E-Learning – Addressing Impurities In Pharmaceutical Products

OVERVIEW

This webinar is designed to provide a comprehensive overview of impurities which must be controlled in pharmaceutical products, detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results. Topics for discussion include general impurities (not structurally related to the drug substance), such as residual solvents, elemental impurities, and microbial issues, and drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities. Interaction and questions from the participants are actively encouraged throughout, and there will be ample time for questions at the end of the presentation.

LEARNING OBJECTIVE

Upon completion of this course the learner should be able to:

• Identify the various categories of impurities likely to be present in pharmaceutical products.
• Be familiar with the guidance documents related to the various categories, and have an understanding of the requirements included in each.
• Develop a strategy for addressing each of the categories of impurities, if appropriate for the particular dosage form.
• Report the results of testing consistent with expectations of regulatory agencies.

TRAINING COURSE

1. Overview of Impurities in Pharmaceutical Products Requiring Control
2. General Impurities
3. Residual Solvents
4. Elemental Impurities
5. Microbiological and Endotoxins Tests
6. Drug Related Impurities
7. Process Impurities
8. Degradation Products
9. Potential Genotoxic Impurities
10. Strategies for Control of Impurities

Form Registrasi Pelatihan / Training

Jika anda berkeinginan untuk mengikuti Pelatihan E-Learning – Addressing Impurities In Pharmaceutical Products, anda bisa langsung menghubungi salah satu nomor kami di bawah ini:

• (0274) 4291-355 (08:00 – 16:00)
• 0811 2938 847

Anda juga bisa langsung mengisi Formulir pendaftaran di bawah ini: