In multiple recent FDA warning letters, laboratory data integrity was cited as the main reason for concern. One letter states that the identified data integrity issues “demonstrate a general lack of reliability and accuracy of data generated by the laboratory – a serious CGMP deficiency that raises concerns about the integrity of all data generated by your firm.”
This is of critical importance because without complete, accurate data, the laboratory – and therefore the firm – cannot demonstrate the product has the appropriate identity, strength, quality, and purity as stated in specification. If the integrity of your data is in question, so is the quality and safety of your product.
In order to assure your firm’s data integrity, staff must be kept up-to-date on the handling of laboratory data/results – especially failing or out of specification (OOS) data. And, since the FDA issued the OOS guidance in 2006, both the FDA and the MHRA have communicated additional expectations for OOS handling, including updates to the OOS investigation process and expectations for quality agreements to address OOS communication and management.
Attend this webinar to learn – or refresh your knowledge of:
• The basic tenets that drive laboratory data integrity expectations
• The current expectations for handling OOS investigations – including the process, roles/responsibilities, and expected outcomes
• The differences between the US and new EU expectations for OOS handling
• Expectations for data integrity and OOS management in CMO relationships
• Examples of recent laboratory data handling issues identified by FDA in warning letters and 483’s
• How to prepare your analysts/personnel to operate under these expectations
• How to assess your process for gaps – before the auditors do
This course will be of benefit to anyone working in or with results from a GMP regulated laboratory environment on global or domestic scale. This includes QA, QC, Development, Regulatory Compliance, and management personnel from sponsors and contract manufacturers (CMO) alike. Anyone who’s tasks include generating and reviewing laboratory data, auditing OOS handling processes, or participating in/overseeing the investigation of OOS results.
Joanna Gallant is an experienced, solutions-driven Quality professional with over 20 years of technical and operational experience within pharmaceutical, biotechnology and medical device manufacturing environments. Over her career she has provided regulatory, technical, skill and management development training support to all Operations functions as well as IT, R&D, Customer Service and senior management.
Over her career, she has held positions in quality assurance, laboratory and training roles, which enables her to translate operational experience into training. She has established and led multifunctional and global project teams, and worked both as an individual contributor and a manager, and can speak from various perspectives as a result. She is well versed in instructional systems design, problem solving and root cause analysis skills, and she uses these skills to identify problems and solutions for performance and process improvement, and to analyze training systems for gaps and training programs for effectiveness.
Joanna regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based training, and interactive training design. She has been in leadership positions in the Massachusetts-based BETA organization for the last 10 years, and was asked to join the GMP TEA, Inc. Board of Directors in 2008. She was one of the founders of and was an instructor in the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011.