2-Hour Kymanox Knowledge Bar Course:
Review Core CGMP and Data Integrity Principles
Followed by The Frontier Happy Hour Sponsored by Kymanox
The Kymanox Knowledge Bar is officially open, and we are hosting a 2-hour event to provide core training on Current Good Manufacturing Practices (CGMPs) and Data Integrity for life science companies. Our workshop will consist of two training modules that will help any team, whether brand new or seasoned. We will provide certification documentation so that your organization may count this towards required annual FDA compliance training. Quizzes and certificates of completion will be provided following the training.
Come join us for an afternoon of learning and networking on Thursday 07FEB19 at The Frontier campus in Research Triangle Park, NC followed by the Frontier Professional Networking and Happy Hour sponsored by Kymanox. The training includes:
- CGMP Overview presented by Nathan Blazei, RAC, ASQ-COA, Director, Regulatory Affairs. This comprehensive review covers CGMP basics, FDA regulations, the major elements of governing Quality Management Systems, and links to compliance.
- Data Integrity Training presented by Erica Fadool, ASQ-COA, Manager, Compliance. This presentation covers data types, critical data integrity principles, data transcription and review, and 21 CFR Part 11 compliance for e-data.
Each workshop module is approximately 1 hour and will include a Q&A session and quiz. Training certificate to be provided upon completion.
Kymanox is Your Life Science Solutions Partner
As a premier professional services provider in the biologics, pharmaceutical, medical device, and combination products spaces, we are at the forefront of delivering translational (i.e., bench to patient) engineering, scientific, quality, and regulatory support. We are the ideal team to deliver training to you and your organization, especially as it relates to Current Good Manufacturing Practices (CGMP) governed by FDA, EMA, and other regulatory bodies.