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Parenteral Drug Association's 49th Annual Meeting,
    Courses and Exhibition
Sheraton Hotel & Hynes Convention Center
Boston, MA USA
November 13-17, 1995

For further information contact Suzanne Stone
at 301-986-0293 x115 (voice), 301-986-0296 (fax), or
via email at stone@pda.org

Selected Program Highlights

Monday, November 13

Keynote Lecture, "Modern Biological Science and
Pharmaceutical Technology" by Nobel Laureate Phillip
A. Sharp, Ph.D., MIT.  In 1993 Professor Sharp,
currently Head of the Department of Biology at the
Massachusetts Institute of Technology, shared the
Nobel Prize in Physiology or Medicine for the
discovery of split genes in 1977.

Sessions on 
-Sterile Products Issues
-International Conference on Harmonization (ICH)
    -News on ICH standards development
-Cleanrooms
    -Latest thinking about evolution in
environmental monitoring
-Gene Therapy
    -Presentations on manufacturing concerns and
regulatory/quality control issues
-New Drug Delivery Systems
    -Talks on nasal peptide delivery system and a
novel delivery system for protein formulations
-Container/Closure Integrity
    -News about container/closure integrity test
methods


Tuesday, November 14

Special Lecture by inventor Dean Kamen
Dean Kamen is president and owner of DEKA Research &
Development Corporation, a Manchester, NH-based
company specializing in advanced technologies in
medical equipment.  A physicist, engineer and
inventor, Kamen holds more than 30 U.S. patents,
including those for the wearable infusion pumps. 

Sessions on
-Facility Design
    -Considerations for bioprocessing and sterile
bulk chemical plants
-Packaging & Labelling of Clinical Materials
    -Discussions of medical and clinical scenarios,
contract manufacturing (outsourcing for packaging and
labelling), and packaging of blinded material
-Lyophilization
    -Presentations about batch uniformity, moisture
analysis, biopharmaceutical formulations
-Blow-Fill-Seal Technology
    -Explorations of environmental conditions,
stability, visual inspection difficulties, and
approval of US facilities for parenterals


Wednesday, November 15

Michael S. Korczynski Lecture, "Interaction and
Cooperation Between Industry and Regulators: A View
From Both Sides" by Lennart Ernerot, Ph.D., Chief
Pharmaceutical Inspector, Sweden

Sessions on 
-Inspections/Regulatory Affairs
    -Update on CBER and CDER activities and proposed
regulations and reports on PDA activities with FDA
-Biotechnology Inspection Trends
    -Industry case studies of recent regulatory
inspections


Thursday-Friday, November 16-17

Practically-oriented education courses on 
-Aseptic Processing Validation: Trends & Issues with
James Agalloco, President, Agalloco & Associates
-Steam-in-Place Technology with James Agalloco,
President, Agalloco & Associates  
-Ventilation and Airborne Contamination in Cleanrooms
with Bengt Ljungqvist, Ph.D., Professor, Royal
Institute of Technology, and Berit Reinmuller, Senior
Expert, Microbiology Validation, Pharmacia AB
-Parenteral Packaging and Seal Integrity with Dana
Morton Guazzo, Ph.D., Principal Scientist, Parenteral
Formulations, R.W. Johnson Pharmaceutical Research
Institute; Patty H. Kiang, Ph.D., Director, Technology
Development, and Edward J. Smith, Ph.D., Vice
President, Scientific and Regulatory Affairs, The West
Company
-Fundamentals and Concepts of Calibration and
Metrology -- L. David Duff, President, A-Metrology-Z
-Cleaning Validation -- Rebecca Brewer, Raytheon
Engineers & Constructors, and William E. Hall, Ph.D.,
Hall & Associates
-Validation of Lyophilization -- Robert F. Ryan,
Associate, Lyophilization Technology; and Heather
Pedersen, Merck & Co.
-CGMP Considerations for the Manufacture of Clinical
Bulk Pharmaceutical Chemicals (BPCs) -- Al Jacks, CMC
Quality Assurance Manager, and Julie Niemi, Senior
Compliance Auditor, both of Glaxo Research Institute
-Fundamentals of D, F, and Z Values -- John Shirtz,
Department Head, QA, Glaxo Wellcome Co.


Exhibition

The PDA Annual Meeting includes a booth exhibit
featuring equipment and services for the
pharmaceutical industry.  The exhibit area, with over
150 booths from more than 100 companies, will be open
on Monday and Tuesday from 9:00 am to 4:00 pm and on
Wednesday from 9:00 to 11:30 am.  Coffee breaks are
scheduled each day in the exhibit area.  Box lunches
will be available for sale in the area on Monday and
Tuesday.  Admission to the exhibit area only is free. 
A poster session is scheduled for Tuesday afternoon in
the exhibit area.


Social Events

Monday evening PDA hosts a reception in the exhibit
hall followed by the Annual Meeting banquet.  

Tuesday evening features an elegant reception at the
Museum of Fine Arts Boston.