Khaled Moussally
Executive Vice President Clients & Regulatory Relations, Compliance Group Inc
Khaled is a Quality & Compliance executive and a thought leader providing cutting-edge solutions to Life Sciences industry. After spending over 27+ years with corporate in IT, Manufacturing and Quality, Khaled transitioned into consulting to bring about a paradigm shift in Quality & Compliance by leveraging his experience with regulatory agencies. Khaled is a key participant of the MDIC “Case for Quality Initiatives” and a member of the “FDA – Industry CSA team” contributing to the FDA draft guidance “Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software”. Khaled is on the “ISPE GAMP America Steering Committee” and has co-presented with the FDA in numerous industry conferences on how to reduce CSV cycle times while enhancing quality by applying CSA concept.
Appearances
DateNovember 2, 2021Concurrent Session: Lifecycle Management and Modernization|The focus of this session will be on the implementation of modern computerized systems in the pharmaceutical industry…Session Leader
Executive Consultant, PQE US Inc.Speakers
Principal Consultant, EmergnVP, Compliance & Quality and Data Protection Officer, SuvodaExecutive Director, IT - Quality and Compliance, Gilead SciencesExecutive Vice President Clients & Regulatory Relations, Compliance Group IncBusiness Developer, Körber Pharma Software
DateMay 10, 2023Since the original publication date of GAMP 5 in 2008, the application and use of technology has advanced substantially. GAMP 5 Principles and Framework remain applicable and relevant today…Speakers
Director, TenTenTen Consulting LimitedManager, D-fine GmbHMedicines Inspector, GxP IT, Danish Medicines AgencyDirector, Conformity Ltd.Inspector RPharmD, Bezirksregierung MunsterGuy Wingate, PhDIndependent Consultant, Glaxosmithkline PLC (Retired)Executive Vice President Clients & Regulatory Relations, Compliance Group Inc
DateOctober 16, 2023In this session you will hear about how GAMP 5 Second Edition has had an impact on the pharmaceutical industry, the current FDA position on Computer Software Assurance (CSA) including how organizations are adapting to a CSA environment, the significant areas of progress and, conversely the remainin…Speakers
Executive Director, IT - Quality and Compliance, Gilead SciencesExecutive Vice President Clients & Regulatory Relations, Compliance Group IncProgram Manager, Case for Quality, FDA/CDRHDirector, TenTenTen Consulting LtdDirector, TenTenTen Consulting LimitedDirector, Conformity Ltd.Consumer Safety Officer, FDA/CDRH
DateApril 17, 2024Regulatory panel discussion on the implications and opportunities of CSA draft guidance and GAMP 5 2nd Edition on 21 CFR Part 11 Since the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2023, many questions and concerns have been raised regarding the impact of the gu…Speakers
GMP Inspector, MHRAUnit Manager, Inspection Risk, Control and Governance, MHRAExecutive Vice President Clients & Regulatory Relations, Compliance Group IncProgram Manager, Case for Quality, FDA/CDRHConsumer Safety Officer, FDA/CDRH
