Webinars

  • Seminar Title : Stability Studies, Basics and Industry Practices
  • Time: From 11:30 AM to 1:30 PM
  • Date: From 5th jan 2025
  • Fees: ₹ 0

Dear All,

Greetings of the Day!!

Please join us for important series of webinars on “Stability Studies, Basics and Industry Practices “ which will be held on Sundays from January 2025!!

Meet our esteemed speakers Dr. Saranjeet Singh!🙏🙏

The importance of stability-indicating analytical methods cannot be overstated, especially in the context of FDA 483s and Warning Letters. Our upcoming Online Training course will delve into the intricacies of setting stability studies based on method capability, validation, and stability results. Additionally, we will shed light on managing genotoxic impurities and strategies for their control during stability studies monitoring. The discussion will also encompass Quality by Design (QbD) aspects.

It's crucial to recognize that the accuracy of analytical results, aligned with specifications, is influenced by the measurement's variability, sampling process, and manufacturing process variability. This underscores the significance of considering quality-based results and acknowledging measurement uncertainties when establishing or adhering to specifications.

Specifications for the API (drug substance), excipient(s), and the drug product play a pivotal role in the quality section of the marketing authorization application required for submission to the competent authority.

At Raaj GPRAC, we have meticulously analyzed the challenges and issues prevalent in the Global regulatory landscape. In light of this, we are pleased to announce a SEMINAR on "Global STABILITY STUDIES, Basics and Industry Practices, till Submissions, Approvals." We invite you to participate in our ONLINE Webinars focusing on these critical topics and engage with esteemed Dr. Saranjeet Singh to enrich your understanding.

Please contact us at elearning@raajgprac.com, rajashrio@gmail.com

Best regards,

Rajashri Survase-Ojha

Founder & Director [ DIN-07058128]

GxP, Global RA Consultant, Auditor, Trainer

Lead Auditor ISO;13485-2016, ISO;9001-2015,

ISO/IEC-17025-2017, FSSC-22000,V-6

www.raajpharmaelearning.com