Risk-based Assessment of Pharmaceutical Products using FMECAWEBINAR

by Dr T R Krishnan (Ottawa, Canada)

Wednesday 13 Apr 2022, 16:30 → 17:30 Asia/Kolkata

BIT Mesra

About Speaker:

T R Krishnan, PhD, FCSPS

Dr. Krishnan did his B. Pharmacy (BIT Mesra, 1976-80), M. Pharmcy (Panjab) and Ph. D., in Biopharmaceutics (Dalhousie University, Canada). He served the School of Pharmacy, Memorial University of Newfoundland, as a tenured  Associate Professor for seven years.  He also served the University of Ottawa as Visiting Professor for four years. Krishnan has also worked in the pharmaceutical industry (Astra Zeneca and Patheon) for six years in Formulation Development and Manufacturing of various formulations including tablets, capsules, ointment, liquids, aerosol and injectables. He then worked at Health Canada (HC) for eighteen years in various capacities in pre and post approval submissions before retiring as a Senior Scientific Advisor. He represented HC in ICH (International Council for Harmonization) Expert Working Group for 5 years in different quality topics (ICH Q8, Q8-9-10 implementation and Q12). He is currently serving Health Canada as consultant on contract.  Honours and awards received includes Deputy and Assistant-Deputy Minister’s awards on Innovation & Creativity, Collaborative Leadership, Backlog-Elimination and Claire Franklin Award in Continuous Learning (at Health Canada) and Bristol-Myers Squibb-Professor of the Year (at Memorial University). Krishnan has more than 55 publications and abstracts.

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Abstract of Talk:

Risk-based Assessment of Pharmaceutical Products using FMECA

In the last 15-20 years the pharmaceutical industry has been focusing on risk based ways of conducting business. This includes product development, manufacturing and setting control strategy.  This topic is also addressed in ICH Q9. Clinical assessment has also been based on evaluating risk-benefit of treatment modalities. Thus, a risk-based way of performing tasks has become very important in the decision making process. As the first step it requires identifying what is critical among so many factors that could impact the decision making process. For many years Failure Mode Effect Control Analysis (FMECA) has been used successfully in the engineering industry such as the aerospace, automotive and electronic industries.  The pharmaceutical industry has been using it more formally in the last 20 years. In fact, FMECA can be used in many fields in the pharmaceutical sciences including Quality, Safety and Efficacy. It will help in improving the control strategy to minimize incidences of failure.  FMECA also gives the scientist a very useful tool to look at novel ways of using technology for risk-reduction and evaluate residual risk. 

In this presentation the principles of FMECA will be discussed. Examples from Quality, Safety and Efficacy topics will be used to determine critical quality attributes (CQA) and critical process parameters (CPP) and quantify residual risk. Interactive learning examples will be used to help the attendees understand FMECA principles.

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Session Link:

Click here to join through MS Teams

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An incredible Journey of 50 years of the Department

Come, see and  celebrate the Golden Jubilee of the Department with us

16th -18th December 2022

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List of Quiz Winners:

• SNEHA PERVIN
• GOURAV RAKSHIT
• PRIYANKA CHANDRA
• GARIMA AGRAWAL
• SAMSUR ALI DAFADAR
• KAYNAZ HUSSAIN
• SUVAM CHOUDHURY
• SAUVIK MAJUMDAR
• ANWESH BHOWMICK
• JATIN KUMAR SAHU

Presentation Slide

Presentation Video

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