If you’re in the pharmaceutical and biotech industries, you likely know that Interphex takes place today through Thursday at the Javits Center in New York City.
On Wednesday at 1:30-2:30pm in 1E10, Emerson’s Michalle Adkins will be leading a panel, Road Map to Implementing EBR [electronic batch records] #505. Here’s the description for this panel:
EBR/MES benefits will not be fully realized until you “lean the existing paper Batch Record documentation FIRST.” Companies continue to underestimate their value of addressing the documentation and work flow in order to implement EBR effectively. Documentation often becomes the “step child” when a project schedule is developed with the focus on user requirements planning, sandbox testing and training. The leaning or redesign process eliminates redundant information, identifies what data to integrate to EBR, develops a strategy for interface with other systems, validates and/or invalidates user and functional requirement specifications, and identifies what SOPs need to be revised and created to support and comply with system functionality and interfaces and provides the true ‘road map’ to implementing EBR effectively.
- Criticality of why documentation and workflow should be addressed to effectively implement EBR
- How to evaluate necessary changes that will define URS for EBR
- How understanding the documentation and workflow will help with properly selecting EBR vendors to evaluate
Chuck is the Vice President/Managing Partner at Malcom Associates. He has over twenty years of consulting experience developing and implementing solutions to the pharmaceutical, medical device, bio-technology, animal health, nutraceutical, and healthcare industries. He managed projects to simplify documentation and business processes enhancing cGMP, GLP, and ISO compliance, designing new manufacturing layouts, change control workflows, and develop user requirements/specifications for Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), Electronic Document Management Systems (EDMS), and automation interfaces and integration.
David is the Associate Director, Manufacturing Systems at Bristol Myers Squibb’s (BMS) Large Scale Cell Culture (LSCC) facility in Devens, MA. He received a Bachelors Degree in Chemical Engineering from University College Dublin, Ireland. His career began as a project engineer in the food / dairy industry before transitioning to the pharma sector at Bristol-Myers Squibb in 1999. David has worked in a number of functions at BMS including Manufacturing Operations, Process Engineering, Projects and Technical Services.
I hope to follow up with Michalle in a future post to highlight some of the points from the panel. For those in attendance, I hope the expertise shared helps you in your electronic batch record improvement efforts.