Abstracts and Bios

The Marketing and Advertising Experience

This presentation will focus on the strict regulatory process imposed by the Food and Drug Administration (FDA) on the pharmaceutical industry in the U.S. and its Territories, including Puerto Rico. Participants will learn the steps involved in the regulatory process when presenting the FDA with documentation for marketing and advertising a pharmaceutical product. Key topics of discussion will include label versus labeling, culturalization of promotional material, statutory language, and the objectives of the FDA. Specific sections of the Code of Federal Regulations will be discussed to demonstrate the importance of law abidance and the selection of appropriate words when translating in the pharmaceutical setting. Significant terminology will be presented as well as the importance of using proper terminology and the implications for the medical translator.

Carmen Díaz Zayas is a faculty member and alumna of the Graduate Program in Translation at the University of Puerto Rico, from which she received a post-graduate certificate in Medical Translation. Her teaching experience includes general courses as well as specialty courses in medical, business, and environmental translation. In 1985, she co-founded Atabex Translation Specialists, Inc., a translation agency in Puerto Rico. Since its creation, the agency has offered general translation and interpreting services to private and government organizations in both Puerto Rico and the U.S.

Rafaela Mena is the director of the Drug Information Center of the School of Pharmacy, University of Puerto Rico (UPR), and is also a freelance medical translator. She graduated from the School of Pharmacy, UPR, in 1975 and from the Graduate Program in Translation, UPR, in 2000. She is presently a faculty member of the Food and Drug Administration/University of Puerto Rico joint venture for training the pharmaceutical manufacturing industry in current Good Manufacturing Practices. She also writes for the Puerto Rico Pharmacists Association quarterly publication and translates for the pharmacy journal The Annals of Pharmacotherapy.

Medical vis-à-vis Industrial Environment (Do You Speak Standard Operating Procedures?)

This panel presentation offers a unique opportunity to step into the hands-on, highly regulated world of pharmaceutical manufacturing operations and its documentation requirements. A panel composed of experienced medical and in-house technical translators will address the challenges and intricacies that translators face when working with controlled documents, technical language, and production line argot, as well as interacting with direct end-users and corporate management. Actual members of the Amgen Opus Translation Team, one of the most ambitious translation projects to take place within the pharmaceutical industry, will share their expertise and translation techniques when translating controlled and regulated documentation, including standard operation procedures, batch records, and master formula plans.

Anne C. Jones has been a freelance translator, multicultural consultant, and language instructor since 1988. She has taken multiple and diversified assignments in the science, legal, and business fields under her charge and has a select pharmaceutical client base, including Johnson and Johnson and Procter and Gamble. She holds expertise in the translation of training materials for a multicultural and multinational audience that has proven to be an invaluable asset when she joined the Amgen Opus Translation Team. She has received an MA in Translation from the University of Puerto Rico (San Juan, Puerto Rico) and a BA in Political Science from Radcliffe College (Cambridge, Massachusetts).

José Rodríguez is a translator and document management services coordinator for Amgen LLC in Juncos, Puerto Rico. From the processing and translation of official and controlled documents, including standard operating procedures, manufacturing procedures, validations, and technical reports, to supporting the preparation of manuals, such as Writing Controlled Documents (Spanish), Writing Effective SOPs (English) and Writing Effective Manufacturing Procedures (English), he has been able to provide a unique conduit for the arduous task of developing bilingual technical glossaries and in-house communication guidelines in a highly regulated environment. His background as a consultant for the Department of Public Health, medical information systems specialist, business consultant, and volunteer community leader has earned him numerous awards and recognitions. He is also the translator of several books, including Aquí me quad, Puerto Ricans in Connecticut that was named one of the “ten books that moved Puerto Rico in 1997.” (Carmen Dolores Hernández, Sunday, December 28, 1997, El Nuevo Día). He has received an MA in Social Work from the University of Connecticut (West Hartford, Connecticut) and a BA in Art History from the University of New Haven (West Haven, Connecticut).

What are Good Documentation Practices? Why is the Code of Federal Regulations, Subparts 210 and 211, so often quoted in controlled documents? What is the Food and Drug Administration’s role concerning pharmaceutical processes? What are the psychological considerations to be followed when translating for a highly skilled bi-cultural and bi-lingual work force? A panel of documentation and compliance specialists, as well as an in-house industrial psychologist, will address cultural diversity, register, localization, and regulatory and compliance issues. The session will explore special case studies and demonstrate practical exercises.

Paul B. Conlon, president of PBC Consulting, LLC, is an independent compliance consultant specializing in pharmaceutical and medical device Good Manufacturing Practices (GMP) compliance issues. He has over 25 years of diversified and progressive experience in manufacturing, packaging, validation, training, and quality assurance and is currently working on a long-term client assignment in Puerto Rico, assisting a major pharmaceutical company in developing, implementing, and managing corrective actions required in accordance with an existing consent decree with the Food and Drug Administration. His major client projects include Alpha Therapeutics Corporation, Aventis Behring, Bayer Corporation, Bioport, Eli Lilly and Company, Johnson and Johnson, Medtronic, Merck & Co., and SmithKline Beecham. He has received a BA in Business Administration and Management from Pace University (White Plains, New York) and holds various certifications including First-Line Management from the University of Connecticut, Good Manufacturing Practices from the Center for Professional Advancement, Pharmaceutical Quality Assurance from the New Jersey Pharmaceutical Quality Control Association, and Internal Auditing to the ISO 9000/Q90 Standards from the Quality Alert Institute.

Nicasio Cruz, PhD, is an experienced professional with an extensive background in management development and training. Having created more than 25 training and orientation programs for manufacturing personnel, he can achieve the delicate balance between the technical requirements demanded by the pharmaceutical industry and the correct usage of Spanish as the primary language. Recently retired from Pfizer Pharmaceuticals, LLC (Barceloneta, Puerto Rico) where he held the position of development director for 16 years, he now combines his teaching and dissertation activities with the University of Minnesota, University of Phoenix, Universidad Interamericana de Puerto Rico, and the Pontificia Universidad Católica de Puerto Rico. As a professor involved in graduate and undergraduate business administration programs, he is presently researching the key language terms (English<>Spanish) used in these programs, a study that he hopes will become an important reference source for students, professors, and translators at the local and international level.

Agnes Molina holds a BA in Pharmaceutical Sciences from the University of Puerto Rico and has received certifications from the Puerto Rico Board of Pharmacy License and the Colegio de Farmacéuticos de Puerto Rico. As a validation and quality assurance consultant specializing in pharmaceutical documentation regulatory practices, she has monitored the documentation quality and compliance regulatory practices of several major pharmaceutical plants located in Puerto Rico. She has assisted her clients with quality activities in relation to Good Manufacturing Practices compliance, designed and executed validation protocols and reports for facilities, equipment, cleaning, and packaging operations, and has designed and executed biological product qualification protocols. Her client list includes such industry leaders as McNeil Pharmaceutical, Baxter IV Division, PACO Pharmaceutical Services, Schering-Plough del Caribe, and several validation consulting firms.

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