Our team members are highly qualified professionals having decades of experience in the pharmaceutical and healthcare fields and businesses. They have a real passion and capability to provide the required services in perfect and professional ways. Our methodology for delivering the training and services to the client is to assign the proper experts to complete the mission in an excellent way (make it right the first time is always clear to us)
Furthermore, our training team already worked with FDA, EU, JFDA, CAP, and ISO 15189 approved companies who witnessed many regulatory inspections in this regard. A CV for the trainers will be provided upon request.
Pharmaceutical Team:
Eng. Majdi Ayoub (Pharmaceutical Engineering, Validation, and Quality Trainer): Majdi is a dedicated and results-oriented Qualification & Validation (Q&V) expert and smart trainer, he has a solid and robust background in the Pharmaceutical Engineering, Validation & Qualification (Q&V), and Quality aspects that are applied in both pharmaceutical projects and operation fields.
Majdi has the ability in handling and managing the different pharmaceutical departments and fields to achieve the best harmonization between Quality, Validation, and Engineering aspects. Majdi worked in the different stages of the systems and equipment lifecycle covering the Design, Procurement, Validation, Qualification, and Calibration, in the areas covering sterile/ non-sterile as well as API’s facilities; Production and Packaging Systems, Facilities Management and Infrastructures, Clean Utilities and Computer Software Validation (CSV).
Majdi has a remarkable capability in achieving benchmarking performance through the creation and execution of a creative Qualification & Validation Risk-Based approaches and strategies. He is currently working as a Quality and Validation Manager in German Company (Rieckermann-GmbH).
Majdi has an experience for more than 20 years, during which, he dealt with different inspections and local and international authorities and regulatory bodies (such as FDA, EU, JFDA, SFDA, and others), Moreover, he had implemented different GxP concepts including Engineering and Quality Designs for pharmaceutical facilities, Setting up Project Policies, creating and implementing Projects Qualification & Validation Master Planning(Q/VMP), as well as setting up engineering quality systems and harmonizing them with Quality System or Total Quality Management (TQM) system within the same organization.
Jamal Derkaoui (Pharmaceutical Division): Doctor Jamal eddarkaoui Doctorate in pharmacy and license in economics, ISO 9001/2015 auditor certified by Veritas Bureau, Quality consultant in medical devices ISO 13485/2016 standard. Trainer and consultant in Quality Management, Regulatory Affairs Consultant (registration of health products).
Eng. Mohamed Mejdi BEN KACEM (Pharmaceutical Division): Mejdi has over 20 years in the pharmaceutical industry in Operations and Projects management, he is considered one of unique OSD Process specialist as well as his wide experience as Qualification & Validation Expert for both systems and analytical laboratory instrument
Eng.Lina Rezeq (Pharmaceutical Division): Eng. Lina Rizeq has more than 20-years’ experience in different areas in a multinational pharmaceutical industry covering: quality compliance, Quality Control, Risk Assessment, and Risk Management, Compliance, cleaning validation, process validation technology transfer, and analytical research & development.
Lina has proved track record of achievements such as getting EU approval for the first oncology manufacturing facility in the Middle East, establishing and implementing risk management systems for the manufacturing operation.
Faed Asfour (Pharmaceutical Division): Faed is a highly Qualified Person within the pharmaceutical industry with 17 years’ experience in both sterile & non-sterile pharmaceutical manufacturing, he has a Master’s Degree in Natural Sciences. He is working as a Validation and Calibration Manager in a Pharmaceutical Company in Jordan.
Faed presented different training courses with different operational cGMP topics in Process Validation, Cleaning Validation, cGMP quality, and other systems and equipment validation as well as his exceptional experience with Track and Trace Systems and its Validation requirements.
Asma Abu-Staiteh: Asma has a Master’s degree in “Regulatory Affairs of Drugs and Medical Devices” from Northeastern University- USA. She is the director of our partner office “RADEX for Regulatory Affairs Consultation” that provides professional services and training in Regulatory Affairs. Asma is also the founder and the trainer of the first and only RA diploma in Jordan, named “Regulatory Affairs of Drugs and Medical Devices”
Dr. Nabil Darwazeh (Ph.D.) (Pharmaceutical Division): Dr. Nabil has over 25 years of comprehensive experience in the branded and generic pharmaceutical industries. His experience covers all phases of Pharmaceutical R&D (CMC), Process Developments, Process Scale-Up, Process Optimization, and Validation. Numerous successful projects involving small molecules of new chemical entities and generic products were the focus through his professional years within the pharmaceutical industry. Currently, in addition to the above experiences, he provides specialized training programs in Pharmaceutical Quality by Design, Basic Statistics for non-statistician, Statistical Design of Experiment, Statistical Process Control, and Technical Courses for Manufacture Operators.
Healthcare Team:
Our healthcare team has over 25 years of comprehensive experience in Quality Management, compliance, Safety, diagnostic general, diagnostic molecular genetics, and research molecular genetics laboratories. Their experience covers the management and workflow of pre-analytical, analytical, and post-analytical processes of testing, test validation, instrumental validation, Experimental Design, experimental troubleshooting, Bioinformatics Analysis, Tissue culturing, Stem Cell isolation, management of Reagent Storage system, Certificate of American Pathologist (CAP) Accreditation compliance management and Inspection. She provides training