Usage of Phase-Appropriate Quality Systems in Drug Development

To overcome the challenges faced during the drug development lifecycle, a thorough assessment of quality systems needs to be done in order to determine their application across different phases of the process. During this assessment, all of the elements of the drug product lifecycle need to be considered against the current established systems and processes. This should also involve phase-specific regulatory requirements and current industry best practices.

Join this webinar to learn about how Syngene performed an overall assessment and defined the phase-appropriate quality systems covering preclinical research to clinical-phase studies. While their process is flexible, they have also established proper controls ensuring they maintain the necessary compliance standards.

Key takeaways from this webinar will include how a phase-wise approach can simplify:

• Vendor management
• Quality management systems
• Batch manufacturing, line clearance and QA release

Speaker

Sameer Sharad Bhide, PhD, Early Phase GMP Lead, Syngene

Sameer is the Early phase GMP lead  at Syngene with around 20 years of experience in Pharma- Analytical field and responsible for Method development, QC release, stability testing & Method Validation. Has been responsible for handling varied Dosage forms and API’s dealing with various clients across the globe and worked on molecules from Preclinical till their commercialisation. Has Handled couple of regulatory Audits from Agencies such as US-FDA, PMDA, Russian regulatory.   He has done his Masters from University of Mumbai and Doctorate from Mumbai University institute of  Chemical Technology formerly UDCT Mumbai India.

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