Data Integrity for Microbiology Labs – Under Microscope of Regulators


2-Day In-Person Seminar (Code – INDSEM134)

Data Integrity for Microbiology Labs – Under Microscope of Regulators


    Ahmedabad, GJ, India

 

    November 28 – 29, 2019

Seminar DescriptionAgendaPricingVenue
Data Integrity and Microbiology Lab – Under Microscope of Regulators is a Two days interactive session for exploring and understanding where and why goes wrong in Microbiology Lab which come under Microscopic examination of Regulators.

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.

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.

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 pharmaceutical sectors.

To bridge this gap, this workshop gives you a thorough understanding of the data integrity concerns within the microbiology laboratory and considers all the important steps that can be taken to address identified weaknesses and how to overcome them.

Who Should Attend:

  • Quality Control Departments
  • Quality Assurance Departments
  • Microbiologists
  • Information Technology Departments
  • Regulatory Affairs Departments
  • Data integrity Specialists
  • Laboratory Professionals
  • Research and Development Departments
  • Contract Laboratories
  • Validation Departments
  • Compliance Departments
  • Contamination Control Professionals
  • Monitoring Professionals
  • Product Testing Professionals

DAY 1 : (8.30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

Morning Session:

  • Why has Data Integrity in microbiology become a Hot Topic?
  • Current regulatory expectations (FDA/EU/MHRA) and review of recent inspection findings
  • Data Integrity requirements for microbiological equipment
    • Autoclave cycles
    • DHS cycles
    • Media preparation and reconciliation
    • Plate count
  • Detecting Lack of Data Integrity
  • Data Integrity Directed Towards Microbiological Testing

Afternoon Session:

  • Applying data integrity for microbiological tests, from plate reading to microbiological identification
  • Risk-Based Approach to DI in Testing Sites
  • Running a compliant laboratory
  • What data to be generate as microbiologists, within and outside the laboratory
  • Case Study with example of current 483s
    • Cause of 483s
    • Take away

Q&A and Networking: 4.30 PM – 5 PM

DAY 2 : (9 AM – 4.30 PM)

 
Morning Session:

  • Dealing with computerized systems and data
    • Password policy
    • 21 CFR 211 compliance
  • Variability of microbiological data
  • How microbiological data can be correctly and incorrectly interpreted
    • Plate counts
    • Sterility Test
    • BET test
  • Integrating Human Factors into Data Integrity How should data be controlled and reviewed
  • Good practices in handling metadata

Afternoon Session:

  • GMP Data Integrity Requirements
  • Inadequacies of documents in dealing with DI Issues in Microbiology
  • Application of ALCOA Principles to Microbiological DI Issues
  • Alternative Microbial Test Methods
  • How to pass a regulatory inspection for DI
  • Case study – Data Integrity Risk Assessment

Q&A, Certification, Networking and Close: 4 PM – 4.30 PM

PRICING OPTIONS & REGISTRATION

Seats and Accommodation are limited and based on first-come, first-serve

 

Fortune Landmark – Ahmedabad

Ahmedabad, GJ, India | November 28 – 29, 2019


Call for Assistance: +91-80-4170-0521   Register Now