Data Integrity - Detecting & Mitigating Risk

Date: March 14, 2017
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts!

Course Description:

Data integrity is absolutely critical to the quality and efficacy of finished pharmaceutical products.  Pharmaceuticals manufactured without accurate, trustworthy data cost firms millions in fines, lost sales, and general lack of brand confidence.  Plus, poor data puts the public at risk of using unsafe or under performing medications.  Understanding how to mitigate the risk of compromised data will save you an immeasurable amount of money, time, and stress, plus position your firm in a better regulatory and consumer light.   Join us for this 90-minute presentation where you will learn to minimize risks to your data including:

  • The top five areas where manufacturers make mistakes with their data generation and storage...and how to avoid them
  • Key tips for securing and validating data throughout the data generation process
  • Actionable, practical solutions for designing and implementing data integrity programs throughout your company

This course will benefit anyone working in a pharmaceutical manufacturing environment on a global or domestic scale, including quality, validation, regulatory, and all management personnel from sponsors and contract manufacturers (CMO) alike.  This course will especially benefit those working with pharmaceutical manufacturing data.

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.

Joanna Gallant Pharmaceutical GXP Training Instructor