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Data Integrity: The Foundation Of Medical Product Manufacturing Compliance
September 16, 2021 @ 5:30 pm - 7:30 pm
Alan Taaghol, Ph.D., Director Global Quality Engineering, Corporate Quality, Kite Pharma – a Gilead Company
William Honeck, President, VTI Life Sciences
Mehron Mirian, Director of Automation Services, VTI Life Sciences
Program Manager: Mr. Randy George, Sales Director / Business Development / Account Management, ValGenesis, Inc, Member-at-Large, OCRA
Can there be a practical, pragmatic and compliant approach to data integrity? – by Alan Taaghol, Ph.D., Director Global Quality Engineering, Corporate Quality, Kite Pharma- a Gilead Company
This presentation will begin with the definition and general requirements for data integrity and then dive into the current industry challenges to maintain data integrity in a complex, evolving, globally integrated and regulated eco systems. The later half of the presentation will include approaches and important factors to be considered in solution design that can help ensuring the integrity of data.
Preparing for and Managing Data Integrity Based Inspections – by William Honeck, President, VTI Life Sciences
- Warning Letter Trends
- Essential site documentation – Policies, SOPs, assessments, tools and how to use them effectively
- Create data flow diagrams to demonstrate understanding of data life cycle and system limitations
- Identification and preparation of SMEs for Data Integrity questions
- Prepare for the instrument/system walk-through by investigators
- Manage findings, prioritizing and implementing corrective action plans
- Overview of common findings/issues
Case Study-Level up! – by Mehron Mirian, Director of Automation Services, VTI Life Sciences
This case study is about a real example of establishing data integrity in a company for the first time after a European audit.
- Why do you need to consider Data Integrity?
- Where to start?
- When to start?
- What are the “must do”?
- Who should be involved?
- OCRA Members: $25
- OCRA Government and Student Members: $10, with student/government ID
- Non-Members must register as Members first ($75 for an annual membership)
Mr. Alan Taaghol is the Director of Global Quality Engineering at Kite Pharma – a Gilead Company. Recognized as a program execution leader with twenty-three years of experience delivering world-class creative and game-changing enterprise IT and Quality solutions for global biopharmaceutical, healthcare, and medical device environments. Alan is an industry leader in the implementation, and risk-based validation of GXP regulated computerized systems. He has expertise in compliance with cGMP, GCP, ICH GCP, GLP, 21 CFR Parts 803 & 820, 21 CFR Part 11, SOX, and HIPAA. Also, Alan is a Certified Scrum Alliance Scrum Master and SAFe Certified Product Owner/Product Manager. Alan holds a Doctorate in Electrical Engineering and a Bachelor of Science degree in Physics.
Mr. Honeck is a proven leader with over 30 years of experience in developing and managing Quality Assurance, Validation Services, Information Technology, and Quality Control groups. He has successfully lead numerous commissioning, qualification and validation projects that have included facilities, analytical methods and instruments, and computerized systems at various biopharmaceutical companies within the SF Bay Area. Mr. Honeck has supported multiple data integrity focused inspections, implemented data integrity programs, performed gap assessments and supported data integrity remediation projects. He has extensive experience with implementation and support of Quality Systems including validation, training, change control, document management, CAPA management, and audit programs. In addition, Mr. Honeck has supported multiple Heath Authority inspections.
Mr. Mehron (Ron) Mirian has more than 20 years of experience in the Life Science Industry. Mehron, who holds a BS in Biology, has worked for companies such as Bio-Rad, BBraun, Avid and Molecular Templates in the United States. Mehron currently is the Director of Automation Services at VTI Life Sciences.
Randy George, Sales Director, ValGenesis, Inc., is a Sales and Business Development professional with experience working in the Life Science Industry for domestic and foreign companies selling capital equipment, automation, consulting services, and enterprise systems. In Randy’s current position, he is responsible for sales and account management for the western US offering paperless validation software (VLMS), electronic log manager, and related automation products and services.
OCRA Registration Instructions
It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.
Certificates of attendance will be emailed within two weeks of the event.
Registration deadline is September 14th at noon.
OCRA’s non-profit Federal Tax ID# 33-0630455
If you have any questions or require additional information, email OCRA Program Chair ([email protected]).