Kuumin aihe tällä hetkellä lääketeollisuuden laboratoriossa ja tuotannossa on Data Integrity. Mitä se tarkoittaa ja miten saavutetaan viranomaisten ja asiakkaiden vaatima hyväksyttävä taso? Onko Data Integrityn täyttämisestä jotain muuta hyötyä?

GWB:n järjestämässä seminaarissa käydään läpi asioita, jotka valaisevat, miten saavutetaan vaatimusten mukainen laboratoriotoiminta. Pääpuhuja seminaarissa on teollisuuden asiantuntija Bob McDowall.

Seminaarin keskeisiä asioita ovat:

  • Data Integrityn periaate, Alcoa+ kriteerit
  • Data Integrity ja sen tärkeys
  • US 21 CFR 211 ja EU GMP Chapter 4 tulkinta
  • käytännön esimerkkejä toiminnasta

Seminaari on juuri sopiva henkilöille, jotka työskentelevät

  • QC-laboratoriossa
  • QA:ssa
  • IT-osastolla
  • Laboratoriopäällikkönä
  • Auditoijana

Tapahtuma järjestetään Scandic Helsinki Aviacongress -hotellissa Vantaalla (Robert Huberin tie 4)  6.11.2018 klo 9.00 – 16.30.

Ohjelma:

8.30 Ilmoittauminen ja aamukahvi

9.00 Introduction to Course and Instructor

  • Outline of the day
  • Set expectations and introduction to the trainer

9.10 Why is Data Integrity Important?

  • Background to the current data integrity issues
  • Data Integrity Training for FDA and EU Inspectors: summary of the training
  • Inspection of computerised systems is changing: paper to on-line
  • Summary of recent company warning letters dealing with data integrity
  • Overview of MHRA, WHO and FDA data integrity guidance documents

10.15 Principles of Data Integrity

  • The ALCOA+ criteria for data integrity
  • Paper versus hybrid versus electronic systems
  • Scope: production information versus laboratory data: why are laboratory data higher risk?

10.45 Kahvitauko

11.00 Data Process Mapping to Identify Data Integrity Vulnerabilities

  • What is data process mapping?
  • Example of a data process map
  • Identification of data integrity vulnerabilities
  • Opportunities for improvement

11.30 Control of Blank Forms and Master Templates

  • All Data Integrity guidance documents require the control of blank forms or templates
  • Understanding the regulatory reasoning for control of blank forms
  • Controls for creating and approving the master template and blank forms
  • Do you really want to work this way?

12.00 Lounas

13.00 Presentation: LabX & Data Integrity

  • An Enhanced strategy for Data Integrity – summary of content
  • Summary / Introduction into hands on demos

13.30 Hands on Demos

  • Station 1: XPE Analytical – Standard Preparation
  • Station 2: Tx & XPE Analytical – Smart Sample
  • Station 3: UV-Vis & XPE Analytical – Sample Prep and Integration (LIMS)

14.45 Kahvitauko

15.00 US 21 CFR 211 and EU GMP Chapter 4: Complete data v raw data

  • Why complete data and raw data are important for understanding data integrity
  • EU GMP Chapter 4 requirements for raw data
  • 21 CFR 211 requirements for laboratory records: complete data
  • FDA Level 2 guidance: paper versus e-records
  • Complete data / raw data example for an analytical workflow

15.30 Second Person Review including Audit Trail Review

  • Regulatory and guidance document requirements for the second person review
  • Role and scope of a second person review
  • Which audit trail to review and frequency of audit trail workshop
  • Documenting the review

16.30 Seminaarin päätös

Seminaarin hinta on 400 € (alv 0%) / henkilö (300 € / henkilö, mikäli yrityksestä on enemmän kuin yksi osallistuja) sisältää materiaalipaketin ja täyden ylläpidon. Ilmoittautuminen 26.10 mennessä sähköpostiosoitteeseen: gwb@gwb.fi

Tutustu videoon ”Laboratory Data Integrity with LabX”

Puhujana toimii Bob McDowall.

Bob McDowall (PhD – Director of R D McDowall Limited) is the co-author of the first AAPS FDA meeting on Bioanalytical Method Validation in 1990 and has over twenty years’ experience working as an analytical chemist, including fifteen years’ experience within the pharmaceutical industry working for two multinational companies. He has authored over 900 scientific papers, presentations and posters on bioanalytical methods, analytical method validation, sample preparation, computerized system validation, laboratory automation and LIMS. As a member of the Editorial Advisory Boards of journals such as Journal of Pharmaceutical and Biomedical Analysis, Laboratory Robotics and Automation, American Pharmaceutical Review and more, Dr McDowall is the leader in his field.