Participants in this training course will receive a copy of the copyrighted presentation(s), relevant notes and workshop materials.A certificate of completion will be issued to participants who successfully complete the assessment.Assessment
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterwards about it. Thank you WCS for bringing on board such wonderful experts.
Module 1 - Setting the scene: importance of DI
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterwards about it. Thank you WCS for bringing on board such wonderful experts.
Module 1 - Setting the scene: importance of DI
- Compendium on DI
- What are the principles of DI
- Navigating the maze of DI guidance – which guidance to use for what
- Summary of DI observations to date
Objectives
Understand existing USFDA and EU GMP regulations and guidance for data integrity
Learn requirements for a Data Governance program and Data Integrity Assurance plan
Learn how to link data lifecycle to process centric data integrity business processes
How to continually monitor and improve Data Integrity impacting business processes
Data Life Cycle design and controls
Some advanced Data Integrity topics include
- Roles and responsibilities of different groups in ensuring data integrity
- What data integrity SOPs do auditors expect to see during audits
- What is the Data Integrity triad
- How to validate Data Integrity impacting business processes
- Data Integrity Maturity Model
- Developing critical thinking skills
Who Will Benefit
- Executive management
- Regulatory affairs
- Quality assurance/quality control
- Legal and compliance officers
- Clinical research directors
- Consultants/service providers
- CAPA specialists
- Compliance information managers
- GMP compliance officers
- GMP training managers
- Heads of internal audits
- QA documentation managers
- QA/QC managers and directors
- Quality systems managers
- Systems analysts
- Training personnel
Faculty Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs
