Implementation and Management of GMP Data Integrity in the Laboratory – Recorded Webcast
The issuance of FDA Warning Letters and the recent announcement of the Medicines and Healthcare product Regulatory Agency (MHRA) highlight the increasing focus on data integrity in the laboratory.
In this one-hour recorded webcast, our two Subject Matter Experts provide proven success steps, tips and recommendations for implementing and managing GMP data integrity in the laboratory.
Your Webcast Content Package includes
- Webcast audio/video presentation (live and recording for download after)
- PowerPoint slide presentation
Why Should You Attend
The implementation and management of GMP data integrity in the laboratory is one of the most critical functions in the pharmaceutical industry. Our two presenters, Danielle DeLucy and Dr. James Blackwell’s experience and success in this area will provide invaluable content for your company’s training program.
Areas Covered in the Webcast
- Data integrity-the basics; why its important
- Data integrity regulatory requirements
- What is ALCOA?
- Recent regulatory changes; impact
- What regulators look for
- 20+ common data integrity issues
- Process flow mapping in data integrity
- Criteria for data integrity
- Data governance
- Access controls
- Data integrity citations in Warning Letters
- Detecting and preventing data integrity issues
Who Will Benefit
Industry professionals from many areas who may interact directly with regulatory inspectors or who help prepare for inspections, including:
- Quality Assurance/Quality Control
- Technical Operations
For Customer Care and Group Discounts – Please Contact Us
Phone: (+1) 844.686.5750
Dr. James Blackwell, MBA is The Founder, President and Principal Consultant of The Windshire Group. Dr. Blackwell has been a prominent industry consultant for over twelve years, working on a wide variety of CMC and quality issues for a broad range of companies, investors, and product types at all stages of the product life cycle. Prior to consulting, he held several senior positions in technical operations, manufacturing and process development at prominent operating companies.
Dr. Blackwell is trained as a scientist, engineer and businessman. He received his Ph.D. in Chemical Engineering from Northeastern University. He received his dual M.B.A./M.S. Technology Management from the University of Maryland, and graduated with B.S. Chemical Engineering and M.S. Microbiology degrees from The Ohio State University.
Danielle DeLucy is an industry veteran and specializes in the areas of Quality Assurance and Quality Systems as a consultant. Prior to this role, Danielle has been in the industry for 15 years serving in numerous quality management roles, such as the Director of Product Quality with oversight of sterility assurance practices and numerous filling and packaging operations. Danielle began her career as a Quality Control pharmaceutical microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena with increasing responsibility. She has helped to lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who: 1) are faced with warning letters and consent decrees; 2) wish to improve GxP practices; and 3) need to establish more robust quality systems.
Registrants may cancel up to two working days prior to an on-line course or webinar start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. On-site training can be cancelled up to ten business days prior to training. Windshire will be compensated for any travel cancellation fees. Courses and webinars may be cancelled due to unavoidable factors. Registrants will be notified if a cancellation occurs. Attendees can choose between the recorded (on-demand) version of the webinar or a full refund for any Windshire cancelled webcast.
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