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X-ORIGINAL-URL:https://bawazirpharma.com
X-WR-CALDESC:Events for Prof. Bawazir Pharma Consulting Center
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BEGIN:VTIMEZONE
TZID:Europe/Moscow
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TZOFFSETFROM:+0300
TZOFFSETTO:+0300
TZNAME:MSK
DTSTART:20220101T000000
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230313T090000
DTEND;TZID=Europe/Moscow:20230313T163000
DTSTAMP:20260428T171722
CREATED:20221129T111359Z
LAST-MODIFIED:20230227T114910Z
UID:5595-1678698000-1678725000@bawazirpharma.com
SUMMARY:Basic of Good Manufacturing Practice (GMP) SFDA Explained 13 March 2023 Riyadh
DESCRIPTION:Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center\n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  12 March\, 2023.\n\n\nSAR 1000.00\n\n\n\n\nOVERVIEW \nUnderstanding basics of GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to SFDA GMP guidelines and how to prepare for inspection. This training will also enhance understanding and be beneficial to persons who work in scientific offices\, regulatory affairs\, pharmaceutical manufacturers\, data management\, basic research\, project management and marketing\, etc. \n  \nDownload Brochure Basics of Good Manufacturing Practice (GMP) SFDA Explained 13 March 2023\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the principals of SFDA GMP guidelines.\nDescribe the different types of GMP inspection.\nUnderstand The general GMP inspection components\n\n  \nKEY TOPICS \n\nGMP Legal Framework\nType of GMP Inspection\nQuality Management\nPersonnel\nPremises and Equipment\nDocumentation\nProduction\nQuality Control\nContract Manufacture and Analysis\nComplaints and Product Recall\nSelf Inspection\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nPharma Regulatory Affairs\nFresh Graduate\nScientific Office Managers\nRegulatory Authorities.\nPharmaceutical manufacturers\nPharmacist\nCRO staff\n\n 
URL:https://bawazirpharma.com/event/basic-of-good-manufacturing-practice-gmp-sfda-explained-13-march-2023-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230314T090000
DTEND;TZID=Europe/Moscow:20230314T163000
DTSTAMP:20260428T171722
CREATED:20221129T120003Z
LAST-MODIFIED:20221129T121142Z
UID:5608-1678784400-1678811400@bawazirpharma.com
SUMMARY:Advance GMP I Oral Solid Dosage Form 14 March 2023 Riyadh
DESCRIPTION:Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center\n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  13 March\, 2023.\n\n\nSAR 1000.00\n\n\n\n\nOVERVIEW \nUnderstanding basics of GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to SFDA GMP guidelines and how to prepare for implementation. This training will also enhance understanding and be beneficial to persons who work in product development and Technology transfer\, regulatory affairs\, pharmaceutical manufacturers\, production engineering\, site engineering\, project engineering\, Quality Operations\, facility support services etc. \n  \nDownload Brochure Advance GMP I – Oral Solid Dosage Form 14 March 2023\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the principals of SFDA GMP guidelines.\nDescribe the Pharmaceutical Quality System concept\, objectives and state of control.\nUnderstand the life-cycle stages and Management responsibility.\nDescribe the prerequisite for the pharmaceutical quality system.\nUnderstand the principles of developing\, designing and implementing the Pharmaceutical Quality System at Oral Solid manufacturing facility.\n\n  \nKEY TOPICS \n\nPharmaceutical Quality System (PQS)\nPQS- GMP for Medicinal Products\nPersonnel\nPremises and Equipment\nProduction – Oral Solid Dosage Form\nCase studies and Best practices\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nProduction – OSD\nPharma Regulatory Affairs\nProduct Development\nProduction Engineers\nQuality Assurance\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/advance-gmp-i-oral-solid-dosage-form-14-march-2023-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230315T090000
DTEND;TZID=Europe/Moscow:20230315T163000
DTSTAMP:20260428T171722
CREATED:20221129T121808Z
LAST-MODIFIED:20221129T121808Z
UID:5613-1678870800-1678897800@bawazirpharma.com
SUMMARY:Advance GMP II Sterile Medicinal Products 15 March 2023 Riyadh
DESCRIPTION:Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center\n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  13 March 2023.\n\n\nSAR 1000.00\n\n\n\n\nOVERVIEW \nUnderstanding the Pharmaceutical Quality System is an essential skills for people working in pharmaceutical manufacturing industry. This course will provide an overview of the pharmaceutical quality system for sterile medicinal product as specified in SFDA GMP guidelines and prepare for implementation. This one day course is designed to increase their knowledge in contamination control strategy\, specific technologies and will provide a comprehensive\, yet practical assessment of the regulations. \nThis training will also enhance understanding and beneficial to persons who work in product development and Technology transfer\, regulatory compliance\, pharmaceutical manufacturers\, production engineering\, site engineering\, Quality Operations etc. \n  \nDownload Brochure Advance GMP II – Sterile Medicinal Products 15 March 2023\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the principals of Production Technology for sterile medicinal products\nUnderstand the contamination control strategy\nDescribe the premises for a clean area and clean area monitoring\nUnderstand the principles of specific technology for the sterile medicinal product manufacturing\n\n  \nKEY TOPICS \n\nPharmaceutical Quality System (PQS)\nPersonnel\nEquipment\nPremises clean area and monitoring\nProduction Technology\nSpecific Technologies\nProcessing (Production-Sterilization)\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nProduction – OSD\nPharma Regulatory Affairs\nProduct Development\nProduction Engineers\nQuality Assurance\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/advance-gmp-ii-sterile-medicinal-products-15-march-2023-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230319T090000
DTEND;TZID=Europe/Moscow:20230320T170000
DTSTAMP:20260428T171722
CREATED:20230305T140941Z
LAST-MODIFIED:20230305T155229Z
UID:5831-1679216400-1679331600@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 19-20 March\, 2023 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 5000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 14 March\, 2023.\nSAR 3500.00\n\n\n\nOVERVIEW \nUnderstanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields\, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research\, data management\, basic research\, and marketing\, etc. \n  \nDownload Brochure SFDA Pharmacovigilance System Explained 19-20 March 2023 Riyadh\, Saudi Arabia\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes of pharmacovigilance\n\n\nDefine official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System\nDescribe the component of the PV System\nUnderstand the role and responsibilities of the QPPV\nUnderstand national pharmacovigilance sub-system file (national PSSF)\nRecognize SFDA oversight and processes during the post-approval phase.\nUnderstand ADR case assessment\, PSUR and risk management.\nInteract appropriately with the SFDA regarding PV\nUnderstand the process of PV inspection and audits.\n\nKEY TOPICS \n\nIntroduction to Pharmacoepidemiology and Pharmacovigilance\nPharmacovigilance systems and their quality systems\nPharmacovigilance System Master File\nQualified Person Responsible for Pharmacovigilance in Saudi Arabia\nRisk Management Systems\nManagement and Reporting of Adverse Reactions to Medicinal Products\nPeriodic Safety Update Reports\nPost-Authorization Safety Studies\nSignal Management\nSafety Communication\nRisk Minimization Measures\nPharmacovigilance Inspections\nPharmacovigilance Audits\nBasic concepts of vaccines and adverse events following immunization\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nQPPV\nPharma Regulatory Affairs\nCountry Managers\nScientific Office Managers\nContract Research Organizations (CROs)\nRegulatory Authorities.\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-19-20-march-2023-riyadh-saudi-arabia/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
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