Denis M. Kluba
Senior cGMP validation consultant

Denis has 30 years in industry, the last 18 consulting and managing validation projects in the pharmaceutical field. He has written over 15 Validation Master Plans for new and existing facilities and operations to successfully guide the participants in the performance of the appropriate functions for compliance. He has worked on the validation of classified environments; API, Solids and biotech facility designs; sterilization; water systems; computer systems; cleaning validation activities; process validation development; writing validation master plans; SOPs; protocols; and other compliance activities. Mr. Kluba holds BS and PPD deqree, both in engineering management, from the University of Missouri-Rolla

Denis has an extensive career of consulting specializing in the assimilation of the required regulatory practices into manufacturing organizations. He worked for Raytheon/Washington Group International and AAC Consulting Group as a consultant and manager of technical projects. His career also includes experience with project and operations management in operating companies, consulting and functional development of compliance issues with an organization of ex-FDA officials, working within manufacturing operations on various functions and managing contract validation specialist. This background provides the ideal credentials to understanding cGMP requirements, FDA inspection expectations and the functions to meet regulatory compliance requirements while efficiently manufacturing products. Mr. Kluba' s specialty is the integration of compliance requirements cost effectively into projects and approaching the regulatory implementation by coordinating the necessary systems to meet the prerequisites of cGMP.

Lisa Xu
Director for API and Finished Dosages purchasing from China

Lisa has over 7 years experience in China 's pharmaceutical industry in the sales and distribution area. She has won high recognition in the industry for her U.S. style management and highly acclaimed inputs to China 's medical system reform. Lisa holds an Master Degree from CIAE. She was ever invited to be a Professional Member of AAAS (American Association for the Advancement of Science) since 1998.
Lisa began to work for AlliancePharm Beijing Representative office since Dec.18, 2002 before its founding in 2004 and lasted the work till August 2006. Her diligent work makes most of the customers' satisfactory. Facing all the difficulties, she insists to do all her best with the international consultants and trading partners to service all related customers in China, USA, Canada, United Kingdom, German, and India. She has began to be responsible for ALP PHARM China Operation since August 2006 that has been in the same office of AlliancePharm Beijing Representative since December 2005 and has been continuing all the related work for both Chinese manufacturers and foreign buyers.

For some key APIs, ALP Pharm is the DMF holder controlling all the key ponits on both manufacturing and quality control which helps much to the end buyers in many countries.