More than 10 years working with BASF AG, Ludwigshafen. Responsible plant engineer for cGMP compliant biotech and chemical API production plants. Chairman of BASF’s GMP committee. Active member of DIN standardization institute and DECHEMA (organizer of Achemasia) focusing on GMP relevant biotech processes and validation. Involved in the development of the PIC/S document PI 006 (validation) and of the ICH Q7 GMP guideline for APIs. After BASF working more than 4 years with DIS AG as head of a newly installed GMP consulting division. Since 2002 managing director of gempex – an EU based GMP service providing company  - and of gemro, the Asian representative of gempex.

Today 20 plus years experience in all GMP matters focusing on EU / US GMP compliant biotechnological, chemical and pharmaceutical manufacturing plants. Involved in audit execution, preparation of and assistance during FDA / EMA inspections, GMP trainings and regulatory affairs consultancy (CEP, ASMF, DMF). Still active in many national and international associations (ISPE, PDA, BAH, VIP3000, etc.). Permanent speaker on international seminars and congresses. Author of several scientific journals. Beyond others he has published a unique book about “GMP, Qualification & Validation of API plants”.

Until 2001 working in the US pharmaceutical industry with companies like Pfizer Inc., Carter Wallace Inc., Banner Pharmacaps Inc., Workhardt Americas Inc., and Duramed Pharmaceuticals Inc. (a Barr company). Mostly in the position of a Manager of Production, Director of Technical Services and Regulatory Affairs, later on as Corporate Vice President Technical Affairs. Since 2002 president and founder of IRB Consultants, L.L.C., N.Y.

Working more than 40 years in the field of GMP. From 1973 starting close cooperation with US FDA by being a selected expert member in many working groups focusing on topics like: establishment of OTC drug review and drug listing programs, development of validation standards, establishment of nutritional supplement GMPs, developing SUPAC-IR, and BACPAC guidelines, discussing gelatine BSE problems, and many more. Still member of PhRMA, CHPA, and different FDA working groups. Published more than 30 papers on GMP, and validation. Auditor and Co-auditor of several textbooks. Today working closely with gemro as US representative, giving trainings, consultancy, and coordinating all relevant activities with US FDA, e.g. DMF filing.

Until 1999 owner of a pharmacy with manufacturing licence for drug products. Acting as Qualified Person (QP) according European law and being a honorary GMP inspector. From 2002 to 2006 joining CONCEPT Heidelberg, the most famous GMP training and consultancy company in Europe, working as a project manager, specialized in GMP for APIs (Active Pharmaceutical Ingredients) and Regulatory Affairs. Currently, Barbara is Managing Director of PhACT (Pharmaceutical Advice , Compliance & Training specialized in Drug Regulatory Affairs) GmbH, closely cooperating with gemro for direct filing ASMFs to EMA and CEPs to EDQM, doing the expert review, and the communication with the authority.

Barbara has more than 18 years experience in the European Regulatory Affairs field. Beyond others she worked as an external assessor of the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany. She is co-author and co-editor of the Guide to Drug Regulatory Affairs, published by Editio Cantor Verlag, Aulendorf, Germany. In 2007 she has been appointed as lecturer at ETH (Swiss Federal Institute of Technology) Zurich, Switzerland within the pharmaceutical Master Education. Since 2008 she chairs PDAs European Interest Group “Inspection Trends and Regulatory Affairs”.

Start of professional career as head of department in Gilan Regional water organization. Since 1992 working for several pharmaceutical planning, engineering and service providing companies like PhC – Pharma Consult GmbH in Heidelberg Germany, PIC GmbH Heidelberg, and others. Since 2002 working as senior consultant and certified auditor by gempex, the German based GMP service providing company and gemro, the Asian representative of gempex.

Mohsen has more than 20 years of GMP experience. He was deeply involved in the design, planning, and construction of GMP compliant API and final pharmaceutical production plants. This includes but is not limited to projects for liquid, semisolid, and solid dosage forms of medicines as well as projects for sterile products. He was the project manager for a huge vitamin project in Asia, responsible for the full GMP implementation and finally for the GMP certification by international bodies. Today he is focusing on the 3rd party audits (mainly in the Asian region) GMP compliance consultancy and leading big GMP executing projects..

Start of professional career as the head of QC department of a HK based pharmaceutical company. Since 2001, working in deep consideration of GMP relevant processes and products on the development and analysis of chemical pathways and procedures mainly with the focus on the production of life science products.

Joono has 10 plus years of experience in GMP and GMP related processes. She actively worked on numerous Chinese GMP projects doing trainings and consultancy on topics like risk assessment, SOP preparation and handling, qualification and validation, and many more. She guided a lot of western auditors doing GMP compliance audits and executes 3rd party audits by herself. She is expert in Chinese and western (EU/ US) GMP guidelines respectively and also is involved in CEP/ ASMF/ DMF preparation and filing. She gave several trainings and lectures directly for pharmaceutical companies as well as during public seminars.

Starting 1999 in the Hong Kong Institute of Biotechnology Phoebe mainly concentrated on GMP relevant projects, providing technical support and GMP consultation to Hong Kong based pharmaceutical companies. Giving training to operators on topics like warehouse and packaging operation, production procedures, documentation and many more. Was involved in the TGA cGMP certification process giving the necessary consultation and support for inspection preparation. From 2001 engaged at Seerpharma Pty Ltd., Singapore as a GMP consultant for GMP compliance, quality assurance, validation and training projects. Today is working as senior GMP expert in the gemro’s joint venture.

Having 10 plus years of experience Phoebe is a senior expert in international GMP regulation and topics like GMP compliant operation, process and cleaning validation, production documentation, site master file preparation, GMP trainings, and many more. She is familiar with all of the GMP compliance requirements.

Graduated from China Pharmaceutical University, starting her professional work in 2001, Katie now has accumulated more than 10-year-experience with GMP. She has accumulated her quality management experiences, especially GMP experiences, from total quality management work. She has once been a QA manager and a delegated qualified person. She has experience at first hand in preparation for EU GMP, such as establishing and improving the six necessary quality systems, that is Validation System, Laboratory Control System, Production and process control systems, Quality Assurance System, Material Control System and Documentation System, etc. She knows well how to control the entire quality system fully to meet the GMP requirements.

More than 10 years working with Guangdong Ganhua Group Biochemical Factory, Nanhai Beisha Pharmaceutical Co.,Ltd., Shenzhen Haibin Pharmaceutical Co.,Ltd., Livzon Pharmaceutical Co.,Ltd. in the field of GMP and Regulatory Affairs. Mainly participating in FDA certifications and EU GMP certifications, until now three EU certificates including two API and one sterile final dosage have been obtained. In 2005, an article about cleaning validation in Pharmaceutical Engineering Design Magazine was published. Since the end of 2011, joined into gemro as Manager-GMP services, providing international GMP consulting, training on all aspects of EU/ US GMP, GMP compliance audit and gap analysis, Execution of qualification & validation, Risk assessment, Follow-up of GMP activities, Preparation and review of DMF/ASMF.

George has been engaged in R&D topics for biotech and chemical processes since 1986. Being manager of a R&D department as well as being director, he has been involved into production, process improvement, R&D management and GMP issues. Beyond others he took part in the design review for a multi-purpose clean room workshop for producing hormone and anti-cancer drug products. Over the years he could accumulate abundant experience in R&D section, production process analysis and GMP design review.

George is working for gemro right from beginning and has now nearly 10 years of experience in chemical, pharmaceutical and GMP related processes. He knows the Chinese market best and is expert in knowing on what the Chinese API and pharmaceutical manufacturers need especially with view to international GMP compliance. He is doing the communication to general and production manager to find out the best way on how to support them.