July 27, 2024

 

 

Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences (MCOPS), Manipal Academy of Higher Education (MAHE), Manipal organized the 𝐆𝐮𝐞𝐬𝐭 𝐋𝐞𝐜𝐭𝐮𝐫𝐞 on 27 July 2024 by 𝗗𝗿. Lalit Kumar, Assistant Professor, Department of Pharmaceutics at National Institute of Pharmaceutical Education and Research, Hajipur, Bihar

titled "Analytical Quality by design for Robust Analytics and Regulatory Compliance”. Dr. Lalit shared invaluable insights on Analytical Quality by Design (QbD) approach that enhances robust analytics and ensures regulatory compliance in pharmaceutical development. He also spoke about how QbD facilitates method optimization and control, when critical quality attributes (CQAs) and key analytical method parameters are identified. It integrates risk management and continuous improvement processes to ensure consistent quality and performance of analytical methods. He also discussed how this approach aligns with regulatory expectations by providing a thorough understanding and control of variability ultimately leading to more reliable and reproducible analytical methods, ensuring product safety and efficacy.

𝗗𝗿. 𝗥. 𝗦. 𝗝𝗲𝘆𝗮𝗽𝗿𝗮𝗸𝗮𝘀𝗵 was the master of ceremony, 𝗗𝗿. 𝗥𝘂𝗰𝗵𝗶 𝗩𝗲𝗿𝗺𝗮 introduced the speaker to the audience and proposed vote of thanks. 𝗗𝗿. 𝗦𝘂𝘃𝗮𝗿𝗻𝗮 𝗚. 𝗞𝗶𝗻𝗶, Head of the Department and Dr. G. Gautham Shenoy, Professor and Former Head, took lead roles in organizing this exemplary event.