cGMP Compliance - Top Enforcement Trends To Prepare For

Date: June 18, 2014
Duration: 90 Minutes - Online
Price: $299 - Introductory Rate

Course Description:

Compliance with FDA 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, regulators have stated their intent to increase inspections and audits in 2014, and the data suggests this has already started.  Join us for this 90-minute presentation where you will learn the latest FDA compliance trends, including:

  • Most frequently cited regulatory observations – and the trends for those observations in both the US and EU
  • Why these issues are often cited – proven steps to avoid non-compliance
  • 5 questions you can use to identify areas of concern (before the inspectors do)
  • How to interpret data from 2013 AND 2014, plus prepare for any eventuality

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 nearly 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.
Over Joanna’s career, she has held positions in quality assurance, laboratory and training roles, which enables her to translate operational experience into her training. 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.
Joanna regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based training, and interactive training design. She has been in leadership positions in the Massachusetts-based BETA organization for the last 10 years, and was asked 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.