Presentations & Publications

Publications: 

  1. Monds, H. and Guardino, R., Stability Program with Microbiological Points to Consider Throughout Drug Development in Microbiology in Pharmaceutical Manufacturing, Richard Prince, Ed., 2nd Edition, Davis Healthcare International Publishing, LLC, 2008.
  2. Guardino, Robert F., Early History of Microbiology and Microbiological Methods in Encyclopedia of Rapid Microbiological Methods, Michael J. Miller, Ed., Davis Healthcare International Publishing, LLC, 2005.
  3. Guardino, Robert F, and Jones, Kevin, Selection of Sterility Test Isolators, Contamination Control, Summer 2007.

 

Presentations: 

BASIC MICROBIOLOGY, Presented to the FDA / CDER Office of Compliance, January 20, 2004, Rockville, MD.

CONTRACT MICROBIOLOGY SERVICES – RELEVANT MICROBIOLOGICAL ISSUES, Williamsburg Bio Processing Foundation Conference, July 28-30, 2008-San Francisco, CA.

DISINFECTANT QUALIFICATION from a User’s Point of View, Barnett International, October 21-22, 2002, Philadelphia, PA.

DISINFECTANT QUALIFICATION – An Overview, PDA 1st Annual Global Conference on Pharmaceutical Microbiology, Oct 30, 2006, Bethesda, MD; INTERPHEX2008, March 26-28, 2008, Pennsylvania Convention Center.

PRACTICAL APPROACHES TO STERILITY TESTING, MICROBIOLOGY EVENT OF THE YEAR, Institute of Validation Technology, June 7-11, 2004, Washington, DC; November 10, 2004, Amsterdam, Netherlands; December 9, 2004, Puerto Rico.

STERILITY TEST VALIDATION and CRITICAL PARAMETERS -International Pharmaceutical Academy, April 7-8, 2010, Toronto, Canada.

VALIDATION OF MICROBIOLOGICAL TEST METHODS, MICROBIOLOGY EVENT OF THE YEAR, Institute of Validation Technology, June 7-11, 2004, Washington, DC; November 8, 2004, Amsterdam, Netherlands; December 7 2004, Puerto Rico; FDA/CBER Presentation, Sept 24, 2008, CBER Headquarters, Bethesda, MD; Microbiology Best Laboratory Practices, International Pharmaceutical Academy, Oct 1- 3, 2008, Montreal, Canada. International Pharmaceutical Academy, April 7-8, 2010, Toronto, Canada; June 15-16, 2010, Boston, MA; and April 12-13, 2011, Montreal, Canada.

PDA-TRI Microbiology Manufacturing and Controls of NDA and BLA Products
RELEASE AND STABILITY REQUIREMENTS, Presented to FDA/CDER NDA/BLA Reviewers, Sept 23, 2008, PDA TRI facility in Bethesda, MD.

MICROBIAL DETECTION METHODS and THEIR LIMITATIONS -International Pharmaceutical Academy, April 7-8, 2010, Toronto, Canada; June 15-16, 2010, Boston,MA and April 12-13, 2011, Montreal, Canada.

EFFICACY of ANTIMICROBIAL PRESERVATION, Pharmaceutical Microbiology & Best Practices, International Pharmaceutical Academy, June 15-16, 2010, Boston, MA; and April 12-13, 2011, Montreal, Canada.