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UID:8da57b176f2ef3ce737aea34f5ba7d73@mivado.com
SUMMARY:Effective Project Management in GxP Environment
DESCRIPTION:Effective Project Management in GxP Environment\n\nDescription\
 n\nThis training course aims to deliver more than the usual project basics 
 and will develop the concept of the project lifecycle from initiation throu
 gh to delivery of business benefits\, providing tools to manage all project
  resources. It is specifically targeted to the needs of facility projects w
 ithin the regulated pharmaceutical industry and demonstrates the value inhe
 rent in the use of  “good practice” project management in the regulate
 d pharmaceutical environment. This course is structured around a typical fa
 cility project lifecycle of Project Initiation\, Delivery Planning\, Design
  Planning and Delivery\, Procurement\, Construction\, Commissioning and Qua
 lification\, and Project Close-Out & Review\, and uses case study examples 
 throughout to illustrate key points.\nObjectives\nTo equip participants wit
 h the knowledge and skills to manage projects effectively while ensuring co
 mpliance with GxP regulations.\n\nUnderstand GxP principles: Train particip
 ants on the fundamental principles of Good Practices (GxP)\, including GMP 
 (Good Manufacturing Practice)\, GLP (Good Laboratory Practice)\, and GCP (G
 ood Clinical Practice).\nIntegrate GxP into project lifecycle: Teach how to
  incorporate GxP requirements into all stages of the project lifecycle\, fr
 om initiation to closure.\nDevelop compliant project documentation: Instruc
 t participants on creating and maintaining GxP-compliant project documentat
 ion\, including risk assessments\, SOPs (Standard Operating Procedures)\, a
 nd change control procedures.\nManage risk effectively: Equip participants 
 with tools and strategies to identify\, assess\, and mitigate risks associa
 ted with GxP projects.\nEnsure data integrity: Train participants on mainta
 ining data integrity throughout the project lifecycle\, following ALCOA+ pr
 inciples (Attributable\, Legible\, Contemporaneous\, Original\, Accurate\, 
 Complete\, Consistent\, and Durable).\nApply Regulatory Considerations: Ins
 truct participants to navigate strict regulations governing GxP product dev
 elopment and manufacturing. \n\n\nWhat You Will Learn\n\n\nDefine a common
  language within the pharmaceutical Project Management community\nIdentify 
 the relevant GxP regulations applicable to their projects.\nApply GxP princ
 iples to project planning\,\n\nDefine the relationship between project mana
 gement and the technical aspects of delivering a project: validation\, desi
 gn\, procurement\, construction\, commissioning\, and qualification\n\nIden
 tify the key areas where compliance to cGMP can be positively impacted by t
 he use of "good practice" project management and appropriately manage risk 
 at all stages in the project lifecycle\n\nArticulate the key project manage
 ment concepts\, methodologies\, and tools applicable to each stage in the l
 ifecycle of a typical pharmaceutical facility project\n\nUnderstand the rol
 e of risk management and how it should be integrated into each aspect of a 
 project\n\nEffectively integrate "hard" project management skills\, such as
  cost\, change\, and schedule controls\, with “soft” project management
  skills such as project team building\, management of sponsors and customer
 s\, etc\, to ensure that project objectives are achieved and business benef
 its delivered\n\nApply the principles of “good practice” project manage
 ment within the regulated pharmaceutical environment\, appreciating the sim
 ilarities and differences between facility projects and other project types
 \nImplement practices to ensure data integrity throughout the project.\nEff
 ectively communicate GxP requirements to project stakeholders.\n\nUnderstan
 ding of the Project Management delivery system\n\n\nWho Should Attend\n\n\n
 Personnel entering the facility project management coming from another disc
 ipline within the pharmaceutical industry\n\nThose with 2-3 years of experi
 ence within a project role\, looking to improve their project delivery capa
 bility\n\nEngineers\, project engineers\, quality\, and IT professionals ar
 e likely to support or deliver projects within their roles\n\nManagers who 
 are likely to sponsor projects.\n\nEducation Approach\n\n\nThe course sessi
 ons are illustrated with examples based on case studies\nOpportunities for 
 participants to ask questions and practice their skills.\n\nPractical exerc
 ises include examples and discussions\n\n\nSpeaker\n\nKossi Molley\, Chemis
 t\; LSSBB\; PMP
LOCATION:Online
DTSTAMP:20260917T084249Z
DTSTART:20261027T130000Z
DTEND:20261027T200000Z
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