Regulatory inspectors can, and do, knock on the door to conduct unannounced inspections! Are you unsure if your company can pass a regulatory inspection? An Environmental Health and Safety (EHS) Gap Analysis is a tool that you can use to prepare your company for an inspection and to significantly improve its overall safety program.
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Maxiom Group's Life Sciences blog about the innovative business and IT practices that are redefining biotech, pharmaceutical and medical device companies.
January 11, 2012
How an Environmental Health and Safety Gap Analysis can Improve Safety and “Vaccinate” Your Company Against Regulatory Fines
Posted by: Beth Graham
Tags: Environmental Health & Safety (EHS), Regulatory | No Comments |
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December 13, 2011
Laboratory Maintenance – It Can Make or “Break” R&D
When scientific instrumentation stops working the entire laboratory can be thrown into chaos. Research grinds to a halt as the scientists figure out how to fix the instrument and wait for the service technician to come in and make the repair. The entire process of returning the laboratory to its regular operation can be quite expensive in terms of both time and money. A well designed maintenance program can help reduce loss of time and money when instrumentation in the laboratory breaks down.
Posted by: Gary Lavine
Tags: Facilities, Operational Excellence, R&D | No Comments |
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November 28, 2011
R&D Productivity Keynote Address Kicks-off First Ever Lab Productivity Micro-conference
On November 16th, I presented the keynote address at the first Lab Productivity Micro-conference at the Cambridge Marriott. Over 50 people attended this event which featured seminars and exhibits to help make the laboratory more efficient and compliant.
The focus of my address was how technical and business cultures impact R&D productivity. Life science companies require technically trained experts and business professionals to work together productively in order to be successful. But lab scientists and industry management often have different priorities and training. These cultural differences can negatively impact R&D productivity if they are not understood and managed effectively.
Posted by: Gwen Acton
Tags: Operational Excellence, R&D | No Comments |
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October 31, 2011
OE in Laboratory Operations Generates Discussion at Life Sciences Industry Meeting
Recently, 21 industry experts gathered at the second meeting of The OE Collaborative, an operational excellence working group hosted by Maxiom Group. Fred Greulich, Vice President of Operational Excellence at Maxiom Group along with a guest speaker presented on the topic “Operational Excellence in Laboratory Operations”. Continued
Posted by: Derek Koziol
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September 12, 2011
Steering Team Selection Can Make or Break Your Project
Maxiom Group recently completed an engagement with a large pharma client looking for process improvement in an R&D project with global site impact.
At the onset of the project, the client coordinated team roles and responsibilities (sponsor, team leader, steering team, and project team). They identified individuals who needed to be involved and made it clear that they had leadership support behind them.
Continued
Posted by: Derek Koziol
Tags: Operational Excellence, Project Management | No Comments |
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August 16, 2011
Health 2.0: Crowd-Sourcing Life Sciences
Social computing is transforming the business model of life science companies by increasing knowledge exchange between consumers, professionals and researchers leading to faster product trials and discovery (Wicks et al 2011, Allison 2009), improved customer service, regulatory reporting and compliance, and streamlined research and development. Health 2.0 in a convergence also labeled Web 2.0, social media, crowd-sourcing and open source science represents a new research model where participant observation, narrative and aggregate data assumes greater importance allowing communities to conduct research projects such as Patientslikeme.com’s lithium research (Brownstein et al 2009).
Posted by: Tim Batchelder
Tags: Crowdsourcing, Health 2.0, Open Source, Personalized Medicine, Social Computing, Social Media, Web 2.0 | No Comments |
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July 25, 2011
Engagement Spotlight: NDA Submission Planning and Project Management
OBJECTIVE
Maxiom Group collaborated with our client to create an integrated NDA (New Drug Application)submission plan and designed an overall project management approach to manage the execution of the plan, resulting in the successful development of the NDA.
Posted by: Scott Chizzo
Tags: Commercial Launch, NDA, Project Management | No Comments |
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June 20, 2011
RFID in Pharma: Let the Revolution Begin (Again?)
There was a time when RFID, or radio frequency identification, was hailed as the silver bullet for pharma supply chain safety and security. Tiny RF chips could hold vast information, from lot numbers to shipping temperature histories, and transmit the data seemingly effortlessly to manufacturers and their supply chain partners. It was the same essential technology that changed the paradigm of our highway tolling (with EZ Pass and similar automated systems), the thinking went, so why couldn’t it do the same for our drug superhighways?
Posted by: Paul Thomas
Tags: RFID, Supply Chain | No Comments |
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June 13, 2011
Is Process Development ready to meet the future? Using a SWOT framework to help find out
Maxiom Group was recently been engaged by a mature BioPharma development organization to help various subgroups (e.g. cell-line development, cell-process development, analytical development) determine their readiness to meet a very different future from what they’re used to, including a much more diverse pipeline, tighter management of costs, greater focus on outsourcing and strategic alliance management.
Posted by: Fred Greulich
Tags: Operational Excellence, Process Development | No Comments |
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June 7, 2011
Data Access: Limiting Factor for Sales and Clinical Supply Planning Performance
At a recent gathering of the Life Science Supply Chain Working Group hosted by Maxiom Group, 18 industry professionals met to discuss the commercial Sales and Operations Planning (S&OP) Process and the Clinical Demand and Operations Planning Process (CD&OP). The moderated panel, which included representatives from Biogen, Genzyme and Pfizer, discussed the current state of their processes, the issues and challenges associated with them. Methods for improving these critical business processes were explored through interaction with the audience.
Posted by: Scott Chizzo
Tags: C&OP, Clinical Supply Chain, S&OP, Supply Chain | No Comments |
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