Course: Practical Insights into Data Integrity for the Regulated Environment
If you work in a regulated environment, our upcoming one-day online course ‘Practical Insights into Data Integrity for the Regulated Environment’ is one that you cannot afford to miss.
This one-day course, led by Dr. Bob McDowall, renowned data integrity expert in the pharmaceutical industry, will provide:
- an understanding of the current expectations of the FDA and EU inspectors regarding data integrity.
- an approach to assessing a process and identifying integral vulnerabilities.
- practical insights into how to deal with issues and investigations which may arise during the data integrity process.
What can you expect on the day?
The day will be broken up into informational talks, Q&A sessions, and virtual workshops. Running from 9am to 5pm, there will be a few comfort breaks and a 30-minute lunch break. At the end of the course, all attendees will receive a Certificate of Completion.
Topics covered on the course
- Data Integrity – a brief refresher
- Understanding the cost of non-compliance
- Understanding complete data, raw data, and metadata
- Audit Trail Review
- Nightmare on Lab Street: Hybrid systems
- How to assess a process and identify data integrity vulnerabilities
- Can spreadsheets meet data integrity requirements?
- Data integrity investigations
- Regulatory Citation: When presented with a regulatory citation, what would you do.
- Audit Trail Review: Review a CDS data audit trail for any issues.
- Identify data integrity vulnerabilities in an analytical process. If vulnerabilities are identified, recommend short-term remediation and long-term solutions.
- Facilitated discussion of a data integrity investigation
- Identify data integrity issues, if any, in each scenario?
One lucky attendee will win a signed copy of ‘Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories’.
Written by our course leader Dr. Bob McDowall, the aim of this book is to provide practical and detailed help on how to implement data integrity and data governance for regulated analytical laboratories working in or for the pharmaceutical industry.
About Dr Bob McDowall
- 6 years’ experience with a PhD in forensic toxicology and 15 years pharma experience at two major pharmaceutical companies.
- A consultant, author, and trainer for 28 years and also a trained auditor
- Bob has been involved in specifying software as a user since 1980 and was trained in computerised system validation (CSV) in 1986. He also has IT infrastructure qualification experience.
- He is acknowledged for industry expert input and review to ‘GAMP Guide on Records’ and ‘Data Integrity 2017’ as well as the ‘GAMP Good Practice Guide on Data Integrity Key Concepts 2018’. Bob was a member of the core team for the ‘Good Practice Guide Data Integrity by Design 2020’
- Bob is the author of books on the Validation of Chromatography Data Systems 2nd edition (2017) and Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories (2019)
- He writes the Focus on Quality column for Spectroscopy and the Questions of Quality column for LCGC Europe
Interested in attending?
Register to attend
The cost to attend is €120 per person.
Payment is via credit card in advance or PO for Mason Technology account holders.
If you would like to attend, fill in the form below and we will be in touch to confirm your place. Alternatively, you can contact the organising team directly using the details provided.