cGMP Compliance - Understanding The Top Drug Enforcement Trends

Date: January 24, 2017
Time: 1:00pm-2:30pm, EST US
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts!

Updated for 2017!

Course Description:

Compliance with Good Manufacturing Practices (GMP) is a constant source of energy, cost, and stress for pharmaceutical and biopharmaceutical manufacturers, and staying abreast of ever-changing regulations can be a struggle.  Plus, as regulators are sharing information and harmonizing approaches, existing data suggests common areas of issues being found by multiple inspectorates.

Join us for this 90-minute presentation where you will learn the latest cGMP compliance trends, including:

  • Most frequently cited regulatory observations – and the trends for those observations in both US and EU inspections
  • Why these issues are often cited
  • Areas of interest to be prepared for – the changes to the landscape that will affect/drive inspections in the future
  • How to identify areas of risk/concern in your own operation before the regulators do – steps you can take to avoid noncompliance

Some areas of increased inspectorate scrutiny include:

  • Data Integrity
  • Supplier Quality Agreements
  • Quality Metrics
  • And more!

This course will benefit anyone working in a GMP regulated environment on both a global or domestic scale, including quality, validation, regulatory, and all management personnel from sponsors and contract manufacturers (CMO) alike.  Additionally, those who need to be able to communicate with manufacturing personnel will find this course extremely beneficial.

Joanna Gallant is an experienced, solutions-driven Quality professional with over 20 years of technical and operational experience within pharmaceutical, biotechnology and medical device manufacturing environments.  Over her career she has provided regulatory, technical, skill and management development training support to all Operations functions as well as IT, R&D, Customer Service and senior management.

Joanna has held positions in quality assurance, laboratory and training roles. She has established and led multifunctional and global project teams, and worked both as an individual contributor and a manager, and can speak from various perspectives as a result.  She is well versed in instructional systems design and possesses highly efficient analytical problem solving and root cause analysis skills, which she uses to identify problems and solutions for performance and process improvement, and to analyze training systems for gaps and training programs for effectiveness.  She has demonstrated the ability to drive culture change and accountability through training and to inspire change and continuous improvement at the operator level as well as through management.  Joanna has successfully represented the training function to regulators from around the world, and quickly develops a positive rapport with auditors.

Joanna regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based training, regulatory requirements, and interactive training design.  She has been in leadership positions in the Massachusetts-based BETA organization for the last 10 years, and was invited to join the GMP TEA, Inc. Board of Directors in 2008. She is one of the founders of and an instructor in the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011.