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UID:5a099d1247b81a2896911aab0907c847@mivado.com
SUMMARY:A Deep Dive into Health Canada's NHP GMP\, GUI-0158\, Version 4: Yo
 ur Blueprint for Compliance
DESCRIPTION:Training is also available in French\nThis intensive one-day wo
 rkshop provides an in-depth review of Health Canada's Good Manufacturing Pr
 actices Guide for Natural Health Products (NHP GMP: GUI-0158)\, Version 4.\
 nParticipants will gain a thorough understanding of the updated regulatory 
 requirements and their implications for all aspects of NHP manufacturing\, 
 packaging\, labeling\, importing\, and distribution.\nThe training will foc
 us on key changes\, including the reorganization of the guide to align with
  the regulations\, the new emphasis on quality systems and risk management\
 , and the enhanced guidance on data integrity and documentation. Through in
 teractive sessions\, case studies\, and practical examples\, participants w
 ill learn how to implement and maintain a robust quality system to ensure c
 ompliance and product quality.\nObjectives\nThis training course aims to pr
 ovide professionals in the natural health product (NHP) sector with a thoro
 ugh understanding of the new Good Manufacturing Practices (GMP) regulatory 
 requirements and to prepare them for their implementation:\n\nUnderstand th
 e key changes and new structure of GUI-0158\, Version 4. This objective foc
 uses on identifying and comprehending the updates from the previous version
 \, including the reorganization of the guide\, the new emphasis on quality 
 systems\, and alignment with other Health Canada documents.\nComprehend the
  fundamental principles of a Quality System and Quality Risk Management. Th
 is objective aims to equip participants with a deep understanding of how a 
 robust quality system and a risk-based approach serve as the foundation for
  GMP compliance.\nIdentify and apply the specific GMP requirements for natu
 ral health products. This objective focuses on the practical application of
  the guidance\, including requirements for premises\, equipment\, personnel
 \, sanitation\, and operational controls.\nlearn how to implement effective
  documentation and data integrity practices. This objective highlights the 
 critical importance of accurate record-keeping\, from specifications to bat
 ch records\, and ensures participants understand the principles of data int
 egrity as outlined in the new guide.\nUnderstand and manage the product lif
 ecycle from a GMP perspective. This objective covers the entire product jou
 rney\, including stability\, handling complaints\, and implementing a robus
 t Corrective and Preventive Action (CAPA) system for continuous improvement
  and compliance.\n\nAt the end of this training\, participants will be able
  to apply new GMP requirements\, minimize non-compliance risks\, and optimi
 ze the quality of their natural health products.\nContents\nThe training is
  structured into four main modules\, with breaks and a lunch period to allo
 w for optimal learning and engagement.\nModule 1: Introduction and Key Chan
 ges\n\nWelcome and Introductions: Trainer and participant introductions.\nS
 ession Objectives: Overview of the day's goals.\nOverview of GUI-0158\, Ver
 sion 4: Understand the purpose\, scope\, and target audience of the updated
  guide.\nKey Changes and Rationale: Discuss the major updates from Version 
 3\, including the new structure\, user-friendly language\, and alignment wi
 th the Quality of Natural Health Products Guide.\n\nModule 2: The Foundatio
 nal Pillars of GMP\n\nQuality System: Delve into the core concept of a qual
 ity system as the overarching framework for compliance. Learn about the rol
 es of senior management and the Quality Assurance Person (QAP).\nQuality Ri
 sk Management: Explore the principles of a risk-based approach to GMP. Disc
 uss how to identify\, evaluate\, and control risks to product quality based
  on scientific knowledge.\n\nModule 3: Core GMP Requirements\n\nPremises an
 d Equipment: Review the requirements for designing\, constructing\, and mai
 ntaining premises and equipment to ensure sanitary conditions and prevent c
 ontamination.\nPersonnel: Discuss the importance of adequate education\, tr
 aining\, and experience for all staff involved in GMP activities.\n\nModule
  4: Operational Control and Documentation\n\nSanitation Program: Learn how 
 to develop and implement effective sanitation programs\, including cleaning
  and sanitizing procedures.\nOperations: Examine the requirements for manuf
 acturing\, packaging\, and labeling\, including batch records and in-proces
 s controls.\n- Specifications and Records: Focus on the critical role of do
 cumentation. Discuss requirements for raw material specifications\, finishe
 d product specifications\, and the retention of records. This section will 
 also cover data integrity and electronic records.\n\nModule 5: Product Life
 cycle and Compliance\n\nStability and Samples: Understand the requirements 
 for stability testing to support product shelf life and the proper handling
  of retention samples.\nComplaints\, Recalls\, and Returns: Review the proc
 edures for handling product complaints and executing an effective recall sy
 stem.\nCorrective and Preventive Action (CAPA): Introduce the CAPA process 
 as a tool for continuous improvement\, including how to investigate deviati
 ons and implement corrective measures to prevent recurrence.\n\nModule 6: Q
 &A and Final Review\n\nInteractive Discussion: Open forum for questions and
  answers.\nSummary of Key Takeaways: Recap of the day's most important conc
 epts.\nNext Steps and Resources: Provide guidance on how to apply the learn
 ed principles to their specific operations.\n\nWho Should Participate\nThis
  session is intended for quality managers\, manufacturers\, formulators\, a
 nd all stakeholders involved in the production and distribution of NHPs. Th
 is training will cover all key aspects: quality management\, process valida
 tion\, raw material control\, packaging\, labeling\, distribution\, and pre
 paration for Health Canada inspections.\nPedagogical Approaches\n\nInteract
 ive presentations and case studies\nPractical exercises and scenarios\nQ&A 
 and discussions on compliance challenges\n\nTakeaways\n\nTraining materials
  and certificate of attendance\nDocument Templates: QMS\, QRM\, CAPA\, Data
  Integrity\, etc.\n\nSpeaker\nKossi Molley\, Chimiste\; LSSBB\; PMP
LOCATION:Online
DTSTAMP:20260415T223650Z
DTSTART:20260512T130000Z
DTEND:20260512T200000Z
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