The regulatory environment is changing quickly around Good Distribution Practices (GDP) for time and temperature sensitive Life Science products, with new or recently revised GDP regulations worldwide mandating increased responsibility along the entire supply chain. All entities in the supply chain must show that sensitive products are being stored appropriately. The first step of this process is performing temperature mapping of the areas where sensitive products are stored. There is currently a serious shortage of expertise in the practice
Successful storage area mapping starts with the identification of risk areas in the storage area where unacceptable variations in temperature and humidity may pose a risk to product quality. Once the areas of risk have been identified, and the storage area’s environmental variability has been adjusted, a mapping test should be conducted to document the temperature uniformity of the storage area in a qualification protocol. This protocol is the proof that the environment is safe for storage, and must be available for inspection during audits by regulatory agencies, such as the EMA or FDA. It is important that documents clearly explain the work that was done, and provide evidence of the results of the study.
You will be interested in this webinar if you need to perform a mapping study, if you are responsible reviewing mapping protocols, or if you want to improve your existing mapping process. In this webinar we will discuss the required elements of mapping qualification protocols and how the protocol guides the mapping activities. We touch upon other validation documents that support the mapping qualification, such as the Validation Master Plan, and the proper reporting of results.
Sign up now. If you have a space to map and you want to understand how to create a reliable mapping qualification protocol, this webinar is for you. Only by gaining this experience, will you have the knowledge to properly design, create, or review a protocol that will satisfy the increasing demands of regulatory agencies.
Paul Daniel,
Senior Regulatory Compliance Expert
Paul Daniel is Senior Regulatory Compliance Expert at Vaisala. He has fifteen years of validation experience in the pharmaceutical and medical device industries. He has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network and computer validation. He has an extensive practical grounding in applying the GMP principles found in 21 CFR Parts 11, 210, 211, and 820. His specialties include: authoring and executing validation protocols (IQ and OQ) for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines.
- Understand Validation Basics
- Understand the relationship between Validation and Mapping
- Explain the Documents used to support a Validation
- Explore a typical Validation Mapping Protocol
- Regulatory Managers
- Metrology Managers
- Quality Managers
- Validation Managers
- Facility Managers
- Stability Managers
- Warehouse Managers
- Laboratory Managers
- Logistics Managers
- R & D Managers
