Archive for November, 2012

ePedigree and Serialization – The January 1, 2015 Deadline

Wednesday, November 28th, 2012

ePedigree & Serialization News Subscription: Starting January 2013, Maxiom Group will be providing a FREE monthly eNewsletter that will provide an update on the current status of these regulations to our clients and other pharmaceutical, biotechnology and medical device companies. SIGN-UP NOW

The word on the street is that the California State Board of Pharmacy’s 2015 deadline for new regulations on drug product serialization and ePedigree will not be pushed back. How is your company preparing your supply chain to handle these new regulations?

(more…)

Tags: ,
Posted in Uncategorized | No Comments »

The Power of Workplace Organization in Improving Lab Operations

Monday, November 19th, 2012

Workplace organization (5S) is a foundational tool in the lean/operational excellence toolbox. With reasonable levels of training and effort, this tool can be implemented to drive significant benefits, including improved productivity and space utilization and reduced employee frustration.

Maxiom Group partnered with a client on a 5S implementation targeted to achieve these and other benefits in the area of sample retains management.

(more…)

Tags: , ,
Posted in Uncategorized | No Comments »

The Aftermath of New England Compounding Center – Does your Company Have Business Process Risks too?

Wednesday, November 14th, 2012

Many companies operate at risk because they don’t properly identify and manage risk or they are in denial that the consequences of performing at risk could jeopardize their entire business.

A perfect example is New England Compounding Center (NECC), where a nationwide outbreak of life-threatening fungal meningitis was traced back to steroids produced at this center. This outbreak has caused over 354 illnesses, including 25 deaths, in 19 states.  A surprise inspection by the FDA discovered sterility issues which forced them to shut down the compounding center and recall all products.

(more…)

Tags:
Posted in Uncategorized | No Comments »

Scientists are People Too: Life Science Employers are Putting the “Human” Back in HR

Wednesday, November 7th, 2012

I recently had the privilege of attending The BioScience Network’s latest event: “Journey to the Top: How a Biotech Becomes a Top Employer” where senior leaders representing small, mid-sized, and large biopharma firms that have been recognized as “Best Places to Work” gave an insider’s perspective and the steps their organizations took to achieve key milestones and success. The panel included:

  • Sharon Cload, Ph.D., Vice President, Adnexus Therapeutics
  • Lisa Kelly Croswell, Vice President, Human Resources, Vertex Pharmaceuticals
  • Mark Leuchtenberger, CEO, Rib-X Pharmaceuticals
  • Alex Constan, Vice President, Toxicology and DMPK, Infinity Pharmaceuticals

(more…)

Tags: ,
Posted in Uncategorized | No Comments »