Frederick J. Carleton Award
Presented as a tribute to lifetime contributor, past President, past Executive Director, and Honorary Member Frederick J. Carleton, this award is designated for a past or present Board member whose services on the Board are determined by his/her peers as worthy of such recognition.
Recipient:
Stephanie Gray, Director, Corporate Compliance, Boston Scientific
Stephanie is currently the Director of Corporate Compliance at Boston Scientific. She was first elected to the PDA Board of Directors while at FDA as Director, Office of Compliance, CDER. She served as a Board member from 1998 to 2003 and was elected Secretary and served in that office and on the Executive Committee during 2004 and 2005. Over the years, she has also supported many PDA conferences with insightful presentations, both domestic and international, as well being an active member of the Strategic Planning Committee.
Stephanie brought valuable and very unique experience to the PDA Board from her work in the government and in the industry, including serving as a member of the US government’s negotiating team for the Mutual Recognition Agreement (MRA) with the European Union and on the ICH Expert Working Group to harmonize GMPs for active pharmaceutical ingredients, Q7A. This experience along with her thoughtful, global perspective has provided invaluable guidance to PDA and contributed to its success during her tenure and beyond.
Distinguished Service Award
This award is given in recognition of special acts, contributions or service that has contributed to the success and strength of PDA.
Recipient:
Harold Baseman, COO, Valsource LLP
Hal is the Principal and Chief Operating Officer for ValSource LLC. He has over 29 years of diverse experience in the pharmaceutical, biotechnology and medical device industries. Hal is receiving this award for his numerous contributions to PDA over the last 25 years including: participation on the PDA Science Advisory Board, Co-Chair of the Risk Management for Aseptic Processing Task Force, Co-Chair of Technical Report No. 22 revision team, Leader of the Process Validation Interest Group, TRI Faculty member and frequent presenter at PDA meetings.
Jerold Martin, Pall Life Sciences
Jerry is Senior Vice President, Scientific Affairs for Pall Life Sciences and has enthusiastically participated in PDA for almost 15 years. His distinguished service at PDA includes being a contributing member of the Strategic Planning and Program Advisory Boards and numerous Annual Meeting and other Program Planning Committees. He was also Chairman of the 1999 Annual Meeting and has been a frequent speaker, Task Force and Interest Group member and co-author of several PDA Technical Reports related to aseptic processing and filtration.
Gabriele Gori, Quality Assurance Director, Bausch & Lomb, SpA
Gabriele is currently QA/QC Director of the Italian Plant of Bausch & Lomb Inc. He is a founding member of the PDA Italy Chapter, serving two terms as Chapter Secretary and as Chapter President since 2005. His distinguished service consists of significant contributions in organizing several international conferences and other events. He has been instrumental in keeping the Italian Chapter active and has involved PDA in training the Italian Inspectorate. By doing so, PDA has won significant recognition within the Mediterranean Health Authorities.
James P. Agalloco Award
The James P. Agalloco Award is presented annually to the PDA faculty member who exemplifies outstanding performance in education. The selection is based on student and faculty evaluations and is named for James P. Agalloco in honor of his work in developing the PDA education program.
Recipient:
Lynn Torbeck, President, Torbeck and Associates, Inc.
Lynn is a consultant specializing in applied statistics. He has been in the pharmaceutical industry since 1975 and president of Torbeck and Associates since 1988. He is an author and editor, and holds BS and MS degrees in statistics.
Mr. Torbeck is being given this award for his dedication to excellence in training and support of the PDA Training and Research Institute. Lynn has been a TRI instructor for many years providing high quality training and consistently receiving strong ratings from his students for his skill as an instructor as well as for the content of his programs.
Frederick D. Simon Award
The Frederick D. Simon Award is presented annually for the best paper published in the PDA Journal of Pharmaceutical Science and Technology. This award is named in honor of the late Frederick D. Simon, a previous PDA Director of Scientific Affairs.
Recipient:
Brian K. Meyer, PhD
Diego Vargas
Impact of Tubing Material on the Failure of Product-Specific Bubble Points of Sterilizing-Grade Filters, Vol. 60, No. 4, July-August 2006
Brian is a Research Fellow in the Department of Biologics and Vaccines, Pharmaceutical Research and Development at Merck Research Laboratories. He leads a group which focuses on understanding the impact of materials and processes on therapeutic proteins. Brian received his PhD in Biochemistry, Microbiology, and Molecular Biology from the Pennsylvania State University and has a BSE in Biomedical Engineering from Tulane University.
Diego is a Senior Engineer in Vaccine Technology and Engineering at Merck. He is responsible for technical support for Pneumovax® 23 sterile formulation. Diego received a BE in Chemical Engineering and BS in Chemistry from the University of Santo Domingo and a Master’s degree from CCNY.
Distinguished Editor/Author Award
This award is presented annually for the best editor/author of PDA-DHI co-published books as selected by PDA members.
Recipient:
Destin A. LeBlanc
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing
Destin consults in the area of cleaning validation at Cleaning Validation Technologies. He previously worked with STERIS Corporation for over 20 years, primarily in product development and technical service for cleaning and antimicrobial applications. He is the author of two books on cleaning validation, and maintains a web site which is a resource for professionals in cleaning. He is a graduate of the University of Michigan and the University of Iowa.
Theodore H. Meltzer, PhD
Maik W. Jornitz
Filtration: The Management of Organism Removal
Theodore H. Meltzer, PhD is a private consultant to the pharmaceutical and semiconductor industries dealing with fine filtration applications, and with high-purity water concerns. He serves as reviewer for the PDA Journal of Pharmaceutical Science and Technology, Pharmaceutical Technology, and the American Pharmaceutical Review. He is an honorary member of PDA and heads its Pharmaceutical Water Interest Group. Dr. Meltzer holds four patents and lectures and publishes extensively. He received his PhD from the University of Chicago and completed post-doctorate work at Princeton University.
Maik is Vice President Product Management at Sartorius. With over 20 years of experience in separation technologies, he is co-editor and co-author of seven books, five book chapters and numerous scientific papers. He is Treasurer of PDA and editorial board member of multiple scientific publications. Mr. Jornitz received his Diploma in Process Engineering at the College for Advanced Technology in Hamburg, Germany and a PED from the IMD Business School, Lausanne, Switzerland.
Susan Schniepp
Understanding The United States Pharmacopeia and National Formulary: Demystifying The Standard Setting Process
Susan has over 24 years of experience in quality assurance for both the food and pharmaceutical industries and is currently the Manager of Specifications and Test Methods for Hospira, Inc. She has a degree in microbiology from Northern Illinois University. Susan was founder and chairman of the Midwest Compendial Discussion Group and founded and co-chaired the Western Compendial Discussion Group. She has also authored several articles on compendial matters.
PDA Chapter Volunteer Award
The Chapter Volunteer Award recognizes the contributions of PDA members who participate at the chapter level. The award is a special way to acknowledge the extra effort put forth by chapter volunteers.
Recipient:
Mary W. Carver, Senior Manager-Microbiology, Eisai Inc. — Southeast Chapter
Jong-Kuk Kim, Senior Manager, Pall Korea Ltd. — Korea Chapter
Leonard Mestrandrea, PhD, Senior Science Advisor, Pfizer Inc. — Metro Chapter
Claudio Puglisi, Production Manager, S.I.F.I. — Italy Chapter
Traute Ryan, Senior Scientist, Merck & Co., Inc. — Delaware Valley Chapter
Mark Staples, PhD, Vice President, Pharmaceutical Technology, MicroCHIPS, Inc. — New England Chapter
Kikoo Tejwani, Vice President of Quality/Regulatory Compliance, B. Braun Medical, Inc. — Southern California Chapter
Amy Twitty, Business Manager, RMC Pharmaceutical Solutions — Mountain States Chapter
President’s Award
This new award recognizes a PDA staff member, other than Senior Staff, whose exemplary performance has contributed to PDA’s success during the previous year.
Recipient:
Janny Chua
Janny Chua is Manager, Product Operations at PDA and is responsible for publication sales. Janny worked in customer service for six years before joining PDA in 1999 as a Publications Specialist. Janny has always worked independently and with much enthusiasm, taking the initiative to ensure high quality delivery of PDA publications and subscription services. She was instrumental in the launching and maintenance of the digital and online bookstore. Janny is a hard worker and is receiving this award for her exceptional sales performance in 2006, increasing publication sales +35% over the previous year.
Ludy Yo
Ludy Yo is the Web Development Manager at PDA. She joined PDA in 2005 as Assistant Web Manager and was promoted to Web Development Manager in the spring of 2006. Prior to joining PDA, Ludy held positions in electronic media and information technology at a variety of companies. She believes in focusing on the web user and “the rest will fall into place.” Ludy has an MA in Visual Communication and Technology Management from New York University. She is receiving this award for her role in the development and design of PDA’s new website, which was successfully launched in December 2006. As evidence of the user “friendliness” of the new website, since its launch, online registrations have increased to over 70% of all registrations.