About course section
Description:
This course covers the International Council for Harmonisation (ICH) guideline Q6A, focusing on specifications for test procedures and acceptance criteria for new drug substances (DS) and drug products (DP). The guidelines outlined in ICH Q6A are crucial for ensuring the quality of pharmaceutical products and protecting public health.
Key Highlights:
- Understanding ICH Q6A guideline
- Setting specifications for new DS and DP
- Defining test procedures and acceptance criteria
- Ensuring pharmaceutical product quality
What you will learn:
- Comprehensive overview of ICH Q6AGain in-depth knowledge of the ICH Q6A guideline and its implications for setting specifications.
- Setting quality standardsLearn how to define test procedures and acceptance criteria to ensure the quality of new drug substances and products.
- Protecting public healthUnderstand the importance of adhering to ICH guidelines in safeguarding public health through quality pharmaceutical products.
Trainer - Bhaumik Modi
Mr. Bhaumik Modi brings over 20 years of rich experience in pharmaceutical regulatory affairs, with a strong focus on US Generics and 505(b)(2) NDA applications. His expertise spans FDA guidelines, regulatory intelligence, and complex submissions, including over 300 ANDAs and 1000+ deficiency responses across CMC, labeling, BE, and clinical studies.
Known for his deep understanding of US and ICH regulatory frameworks, Mr. Modi has successfully managed a wide range of dosage forms and played a key role in achieving First Cycle Approvals through innovative use of AI tools and strategic pathways. He has actively supported high-level regulatory meetings and initiatives under GDUFA III, ensuring smooth approvals and business continuity.
As a trainer, Mr. Modi is passionate about sharing real-world regulatory insights with pharma professionals. He bridges the gap between theory and practice, making complex topics accessible and actionable for learners across functions.