Articles

Members of OsoBio’s leadership and scientific staff often publish articles through a number of media outlets in the pharmaceutical industry. Here are some examples of our published work.

Recent Articles

Several industry magazines have published articles written by or referencing OsoBio experts.

• OsoBio's Kim Ray Featured in PharmTech Podcast about Risk-MaPP
  OsoBio shares how implementation of Risk-MaPP has affected its business as well as its processes.
• Advances in Drug Delivery
  Expansion of biologics drives technology
• Is Six Sigma Still Relevant for Drugmakers?

 

Insider Solutions: A Pharmaceutical Technology feature

Sue Schniepp, VP of Quality and a member of Pharmaceutical Technology's editorial advisory board, is a featured columnist for the publication. Her recent work includes:

• Know the Regulations
  The contract provider needs to know as much as the NDA holder.
• Managing the Quality Relationship for a Contractual Agreement
  Defining the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.
  
• Auditing by the Numbers
  Contract organizations must have highly organized teams and plans to accommodate today's audits.
  
• Where in the World is the US Pharmacopeia?
  After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.
  
• Following our Own Instructions
  Why SOPs are rarely followed, often cited, and in need of follow-through.
  
• Insider Solutions: Reporting Equipment Changes
  What to do when your CMO changes the manufacturing equipment line.
  
• Insider Solutions Rule #1: Be in Compliance
  Drug manufacturers have to be more than just "audit ready."
  

OsoBio Newsletter

OsoBio shares its perspective on trends, regulatory compliance and news from the industry through a quarterly electronic newsletter. Some recent newsletters are included below. New subscribers can sign-up here.

• February 2012
• October 2011
• September 2011
• June 2011
• February 2011
• January 2011
• November 2010
• June 2010