Current Good Manufacturing Practices (CGMP) Knowledge Seminar December 2018

Kymanox is a premier professional services provider in the biologics, pharmaceutical, medical device, and combo products spaces, and are at the forefront of delivering translational (i.e., bench to patient) engineering, scientific, quality, and regulatory support. They deliver training to you and your organization, especially as it relates to Current Good Manufacturing Practices governed by FDA, EMA, and similar bodies.

The Kymanox Knowledge Bar™ team is hosting a one-day course that reviews core Current Good Manufacturing Practices (CGMP) principles. This workshop will consist of four modules that can help any team, whether brand new or seasoned and in need of a refresher, to master the concepts of good, solid manufacturing practices within the pharmaceutical space.

The four workshop modules to be delivered are:

• CGMP–Comprehensive review of CGMP basics, FDA regulations, the major elements of governing Quality Management Systems, and links to Compliance
• Good Documentation Practices–Satisfies FDA Annual Training Requirement, covers all GDP basic principles, guidelines for correcting entry errors, and tips for handling all record types
• Data Integrity Training–Over-arching presentation on the types of data, data transcription and review, and 21 CFR Part 11 Compliance for e-data
• CGxP Writing–Overview workshop to learn the standards and techniques necessary to produce accurate, compliant documents with FDA diction

Each module is approximately 1.5 hours, lunch will be served, and take-home materials provided.