Process Failure Mode & Effect Analysis (FMEA)

  • September 18, 2018
    9:00 am - 4:00 pm


15 Allstate Parkway, Suite 600, Markham, Ontario, Canada, L3R 5B4

Certification Areas

Two primary principles of quality risk management are:  a) The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and b) The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk. The pharmaceutical industry and regulators assess and manage risk using recognized risk management tools and/or internal procedure. Failure Mode and Effects Analysis (FMEA) is one of the tools recognized by industry and regulators.

Course description

This interactive course presents a step-by-step method for conducting Failure Mode and Effects Analysis (FMEA). It defines the role, methodologies, and implementation of FMEAs as an essential component of a Quality Risk Management. Participants will determine FMEA objectives, potential failure cause and effect, assessment of risks, and preventive action plans.



Learning Objectives

·       Understand the different types of FMEA

·       Understand how to identify failure modes

·       Understand how to assess and prioritize risk associated with product and process using severity, occurrence and detection rankings

·       Understand the challenges associated with product and process

·       Through the recognition and evaluation of potential areas of failure,  identify preventative actions and minimise the risk of failure

Who should attend?

·         Those involved in the design or specification of products, processes or services

·         Those involved in business improvement or process improvement management

·         Managers wishing to understand the benefits of FMEA before company implementation

·         Team members involved in a support role


Speaker:  Dr. Chaitanya Baliga

Dr. Chaitanya Baliga has over twenty years of Quality Assurance, Regulatory and Compliance experience in manufacturing, pharmaceutical, medical devices, toy, food, drug, cosmetics, natural health products and other consumer / service industries.

 Chaitanya has a strong understanding of regulations that pertains to Health Canada, FDA, ICH, EU MDD, ANVISA, CSA/UL, and ISO 13485/14971. Chaitanya has successfully developed process improvement / operational excellence/ regulatory compliance / licensing and auditing/inspection training programs in pharmaceutical, medical device and other regulated industries. He is technical committee member for medical devices quality management systems standards. He has presented at several speaking engagements on risk management and risk management tools.

Chaitanya holds a Ph.D. in Materials Science from University of Surrey, UK. In addition, he holds ASQ certifications for Quality Auditor (CQA), Six Sigma Green Belt (CSSGB), and Manager of Quality/Organizational Excellence (CMQ/OE)

Student Ticket: $250.00 Sold Out
Basic Non-Member Single Ticket: $650.00 Sold Out
Group Tickets (5+): $550.00 Sold Out
Pro/Pro Plus Member Ticket Single Ticket: $575.00 Sold Out