Latest Sci-Tech News

• In Print: QbD for Cleaning Validation
  March 2010 We have all heard dreadful stories about delays to submissions, new product introductions and product releases because of failed cleaning validation. These types of costly delays can be prevented if we enter into validation after we are confident that the cleaning cycle is robust and validatable. However, far more than we would like to admit, we have witnessed or heard of events that demonstrate that this has not been the mindset or culture. Many firms have adopted an overkill approach, where they have developed extreme cycles to assure success. These cycles consume excess energy, cleaning agents, and water; increase equipment turnaround times; and produce more waste.
  
  
• Technical Report Watch
  March 2010 See where certain technical reports are within the publishing process.
  
  
• The Challenges of Success – Looking forward to 2010 PDA SciTech Activities
  March 2010 Each successive year, I have had the pleasure to report to you that PDA’s SciTech program has been on an upward trend, as measured by the number of approved Task Forces and participants. In 2010, I expect more teams than ever before in my tenure to complete their goals and publish their deliverables. At the end of February, we will have already published two technical reports, Last Mile: Gidance for Good Distribtution Practices for Pharmaceutical Products to the End User (TR-46) and Preparation of Virus Spikes Used for Virus Clearance Studies (TR 47).
  
  
• Journal Preview: Bio’s CEO writes on Biotech Public Policy
  February 2010 Volume 64, No. 1 (January/February) of the PDA Journal of Pharmaceutical Science and Technology is now available online. This issue has a guest editorial from James Greenwood, President and CEO, Biotechnology Industry Organization, on the public policy that is needed to advance biotechnology innovation. In addition, results from an FDA-sponsored study on the risks of changing sterile drug manufacturing sites are published.
  
  
• Technical Report Watch
  February 2010 Over the years, PDA expert task forces have developed several technical reports on various aspects of filtration. Now you can own all five of them in one easy-to-use hardbound volume.
  
  
• IG Briefing: 13 PDA Interest Group Sessions
  February 2010 The following is the schedule for the 13 interest group sessions that will occur on Monday, March 15 and Tuesday, March 16 at PDA's Annual Meeting.
  
  
• Task Force Corner: Size, Workload Distinguishes PDA's Mycoplasma TF
  January 2010 PDA's Mycoplasma Task Force boasts an ambitious agenda of nine articles, three technical reports and a training workshop. Task Force leader Barbara Potts outlined the group's work at PDA's 4th Annual Global Microbiology Meeting in October.
  
  
• Advisory Board Watch: An Update on PDA's Three Scientific Advisory Boards
  January 2010 The following article is a report on three of PDA's Advisory Boards.