Handling data integrity in the microbiology laboratory

Duration: 60 Minutes
Despite the current high profile, the subject of data integrity in the pharmaceutical microbiology laboratory has not been afforded very much attention in terms of regulatory guidance or in terms of active discussion through articles penned by those working in the pharmaceuticals or healthcare sectors. To bridge this gap, this webinar outlines some of the data integrity concerns within the microbiology laboratory and considers some of the steps that can be taken to address identified weaknesses.
Handling data integrity
Instructor: Tim Sandle
Product ID: 508012
Objectives of the Presentation
  • Understanding the key requirements for data integrity
  • How to pass a regulatory inspection in terms of data integrity
  • Putting together a data integrity risk assessment
  • Understanding data integrity requirements for equipment in general, such as passwords, audit trails etc
  • Understanding the data integrity requirements for microbiological equipment
  • Applying data integrity for microbiological tests, from plate reading to microbiological identification
Why Should you Attend
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data integrity is a key regulatory concern and guidance documents have been produced by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Moreover, data integrity in relation to the microbiology laboratory features in several FDA warning letters, especially in relation to sample handling and reading.

Areas Covered
  • Running a compliant laboratory
  • Dealing with computerized systems and data
  • Variability of microbiological data
  • How microbiological data can be correctly and incorrectly interpreted
  • Ensuring that metadata is captured and reviewed
  • Areas in relation to microbiology where data integrity needs be applied e.g. contemporaneous recording of data in process areas; dealing with zero counts; reading of damaged plates
  • Assessing visual aspects e.g. assessment of turbidity and microbiological staining
  • Case study - how to perform a data integrity risk assessment for a particle counter
Who will Benefit
  • Microbiologists
  • Microbiology managers
  • Quality Control
  • Quality Assurance
  • Information Technology
  • Data integrity specialists
  • Compliance
Topic Background
Data integrity is an important subject and a regulatory 'hot topic'. This subject matter can directly inform an auditor or inspector about the organization, for data integrity issues occur and are identified by auditors as a direct result of poor quality culture within the organization. Microbiology has been relatively overlooked in relation to this subject, in terms of industry guidance. However, inspection trends indicate that regulators are increasingly focusing on microbiology laboratories and the reliability of data. This webinar provides some best practice guidance.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
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