Temperature control is critical for maintaining the integrity of pharmaceutical products. Health Canada’s Guide 0069, “Temperature Control of Drug Products during Storage and Transportation,” mandates that drug products must be transported, handled, and stored within their labeled storage conditions to mitigate the risk of temperature excursions. Whether dealing with ambient, refrigerated, frozen, dry ice, or liquid nitrogen conditions, preventing cold chain failures is essential to protect product quality.
To comply with these regulations, it is important to follow best practices for temperature management across all storage environments, including tanks, freezers, fridges, incubators, rooms, warehouses, trailers, and shipping boxes. GMP Temperature Mapping should be conducted periodically to ensure ongoing compliance and should also be performed following significant changes to equipment or storage areas that could affect air circulation or loading, or when unexplained temperature variability occurs.
Temperature mapping not only fulfills regulatory requirements but also provides valuable data for setting up real-time monitoring systems. This data helps in understanding how temperature deviations can impact products, enabling informed decision-making to maintain product integrity.
This workshop is tailored for Quality Assurance professionals, logistics coordinators, and regulatory compliance specialists involved in the storage and transportation of pharmaceutical products. It is also beneficial for those seeking to deepen their understanding of temperature control best practices and regulatory requirements, especially within the pharmaceutical, biotechnology, and medical device industries.
This workshop covers the following topics:
Understand the core principles of temperature mapping, its importance in maintaining product quality, and regulatory compliance requirements.
Develop Skills in Implementing Environmental Controls:Gain proficiency in selecting and applying appropriate environmental controls and data loggers to ensure optimal storage conditions for pharmaceutical products.
Conduct Effective Temperature Mapping and Data Analysis:Learn to develop and execute a comprehensive temperature mapping protocol, including conducting audits, risk assessments, and analyzing temperature data for compliance.
Prepare and Interpret Temperature Mapping Reports:Acquire the ability to prepare detailed summary reports of temperature mapping findings and understand the implications of non-compliance, enabling informed decision-making and continuous improvement.
All participants will receive a certificate of attendance upon completion of the workshop.
Note: Registration closes one week prior to the start of workshop.
AAPS
Instructor
A Chartered Chemist, her career spans 30 years in the pharmaceutical industry. She started as a stability chemist at Sterling Drug and soon moved to Health Canada where she worked over 13 years in various capacities with the Health Product Branch Inspectorate (HPBI) in the Ontario region. Her expertise include Medical Devices Inspection, Drug GMP Inspection and Compliance issues. She is currently the director of QA/QC at Experchem Laboratories Inc. where she is responsible for overseeing and maintaining the GMP compliance of the chemistry and microbiology laboratory, Auditing, and providing Quality Control Services to importers and distributors.
She has a degree in chemistry from York University and a diploma in Pharmaceutical Chemical Technology from Seneca College.
