cGMP compliance design of Sterile Vaccine Biotechnology | Aziz Chraibi
Summary :
This presentation will cover the up to date according our amazing and innovative approach GAPA (Gap Analysis & Preventive Actions) on cGMP regulations expectations, industry trends and best practices related to design guidelines of Sterile/Aseptic Manufacturing Facilities including layout, sanitary process equipment, clean utilities and pharmaceutical support systems, C&Q, as well as the control quality, quality system requirements and related procedures. This process will be supported by the inclusion of Risk Management strategies (see related ICH Q9 approach workshop) to meet qualification and validation requirements as well as to deal with Biosafety Level of biological compounds according an amazing and innovative approach RAPA (Risk Analysis & Preventive Actions). Such as reported by M. Steven S. Kuwahara: “About 45% of the recalls of drugs and devices are due to design problems”.
About Author :
Dr. Aziz Chraibi, PEng., after having completed his studies in chemical & processes engineering with ENSIACET college of Toulouse (1986), and then a masters at the INP of Toulouse, followed by a thesis doctorate at the University of Perpignan (1990) which was postulated for the best thesis of CNRS award in 1990, began a career of more than 24 years in the pharmaceutical consulting, cGMP compliance and design review, audit and PAI (Pre- Approval Inspection) to meet the good manufacturing practices (cGMP) from Health Canada, EMA and FDA as well as standards such as ISO-14644, ASME-BPE, USP797, USP, EuPh, HSE, NFPA, ATEX, OSHA, ISO, ICH Q9, ASTM 2500, ISPE, ISO-22000, ISO-8573. In 2007, he was registered as Health Canada Scientific and MAPAQ Expert to carry out GMP compliance audit of the pharmaceutical, biotech, food facilities. It has in its assets more than 300 multidisciplinary projects successfully completed in Canada.
