GACP and GMP for Cannabis products

Description:

Good agricultural practices (GACP) and good manufacturing practices (GMP) for Cannabis and Cannabis-derived products training session is intended for producers, master growers, cultivation and operations teams and business executives who are looking to learn more about GACP, GAP/GHP , GPP and GMP and guidelines to standardize and control consistency of cannabis production. This session will explore regulations and compliance through specific requirements for medicinal cannabis, the design and implementation of quality management systems (QMS), including hygiene, what makes a batch, batch traceability, basic record keeping (Good Documentation Practices or GDocP), quality risk management and Corrective and Preventive Actions (CAPA).

Discussion includes

  • Health Canada Good Production Practices
  • USDA Good Agricultural Practices Good & Handling Practices
  • EU Good Agricultural Practice – GAP guidance
  • WHO Good Agricultural & Collection Practice – GACP guidance
  • Overview of standard operating procedures (SOPs) GACP
  • How to develop a Risk Management Plan that ensures a strong value chain of traceability, safety and quality
  • How to identify and address current business gaps for compliance success GACP into GMP
  • How to establish data efficacy and operations efficiency from seed to sale
  • Analyzing GMP from a cultivation perspective

Learning Objective

  • Gain insights into GACP vs GMP and the positive impacts for day-to-day operations
  • Take away simple tools to start implementing GACP growing standards for GMP compliance
  • Better understand what GACP and GMP means for your cultivation teams
  • Assess your business’ readiness for GMP certification and compliance
  • Understand the principles, guidelines, and application of Global GAP (Good Agricultural Practices Standards) for outdoor/indoor medicinal cannabis cultivation and processing up to flower/buds.
  • Understand the benefits of implementing Global GAP principles
  • Interpret requirements in the context of an audit, and from an auditor’s perspective
  • Become informed on how to implement the standard and remedy non-conformance in your facilities
  • Prepare for a third party audit towards certification

Who should attend?

GACP and GAP  principles are recognized globally. So, Anyone producing, manufacturing, or selling food or cosmetic related products needs to take this training.

General Information

– Training material and practical examples will be distributed
– A Certificate of Training completion will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, Chemist, LSSBB, Chartered Trainer – Sr Manager, M&OpEx

Introduction to USFDA 21 CFR Part 11

The 21 cfr part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations.

Objectives

The objective of this free webinar is to share the basic principles of the 21 cfr part 11 Requirements. This session will provide you with information and will allow you to understand the ins and outs of this regulation.

Contents

  • The History of 21 CFR Part 11: When and Why was This Regulation Adopted?
  • What documents and signatures does Part 11 apply to? And what documents and signatures are outside the scope of the regulations?
  • Part 11 Technical, procedural and documentary requirements for electronic records, electronic signatures and open systems
  • FDA Guide to Part 11 Compliance
  • Step-by-step methodology for executing your Part 11 compliance project
  • Actions and Trends in FDA’s Enforcement of 21 CFR Part 11
  • Examples of Recent FDA Warning Letters for Electronic Records Violation
  • Thoughts on the Future of Part 11

Attendees

Anyone interested in USFDA 21 CFR Part 11

General Information

– Training materials will be distributed
– A Certificate of Attendance will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant

Travailler dans un environnement BPF

Objectifs:

Revoir les réglementations récentes BPF applicables aux produits cosmétiques, de santé naturels, pharmaceutiques, et alimentaires.

Ce cours offre une mise à jour des Bonnes Pratiques de Fabrication actuelles basées sur les lois de Santé Canada et les lignes directrices de la FDA. Il comble le fossé entre les réglementations et les règlements les opérations quotidiennes en décrivant les et l’application pratique par le biais des principaux éléments d’un système qualité, essentiels à la conformité aux BPF.

Plan de la formation 

  1. BPF et Réglementations :
    • Réglementation des bonnes pratiques de fabrication de Santé canada et de la FDA relatives aux produits pharmaceutiques, Suppléments alimentaires, instruments médicaux, laboratoires, hôpitaux, PSN et aliments.
  2. Travailler dans un environnement BPF
    • les installations,
    • les utilités,
    • les équipements,
    • les instruments de mesure,
    • la gestion de la documentation,
    • les matières premières,
    • les analyses sur les IPA,
    • les ingrédients
    • les produits finis,
    • le contrôle de la fabrication,
    • le conditionnement,
    • le règlement sur la stabilité
    • les salles blanches.

C’est une formation complète qui présente les différentes difficultés et les approches de solutions conduisant au respect des principes BPF. L’interaction avec les paires permettra d’enrichir notre connaissance.

Le matériel de cours est présenté au moyen de diapositives, de documents et la participation des participants grâce à des discussions et des exercices de groupe.

Participant

Personnes qui travaillent dans les domaines de l’assurance et du contrôle de la qualité, de la production, de la logistique, des achats, des affaires réglementaires et de toute personne intéressée par les BPF.

Matériels de formation

Les participants ont récupéré une copie de la (des) présentation(s), des notes pertinentes et du matériel de la classe de maître. Un certificat de participation sera délivré aux participant(e)s.

Formateur

Kossi Molley , Chimiste, LSSBB, Formateur agréé – Conseiller en gestion

Best Practices of Quality Risk Management

Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. The role of Quality Risk Management (QRM) is integral in supplying and maintaining quality products by evaluating manufacturing processes and understanding risks to product quality and thus patient safety. With a critical understanding of QRM, the quality of products can be built into the manufacturing processes. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks.

Why should you attend?

The Quality Risk Management Master Class helps participants acquire the knowledge necessary and ability to integrate the quality risk management guidelines in an organization. It provides information with regard to the risk management principles and their application, as well as the core elements of the risk management framework and steps for a risk management process. In addition, it provides the basic approaches, methods, and practices for assessing risk in a wide range of GxP situations.

Who should attend?

  • Individuals interested in Risk Management
  • Managers or consultants responsible for the effective management of risk in an organization
  • Individuals seeking to gain knowledge about the risk management principles, framework, and process
  • Individuals responsible for the creation and protection of value in their organizations
  • Individuals interested in pursuing a career in risk management

Learning objectives

This live online Master Class training deals with the best practical implementation of Quality Risk Management (QRM). You will learn how to deploy,  implement and use QRM approaches to increase efficiency and to meet the expectations of the regulators. Also, you will be able to:

  • Demonstrate understanding of risk management principles
  • Establish, maintain, and continually improve a risk management framework
  • Apply the risk management process through the organization
  • Evaluate company’s QRM program against current industry and regulatory expectation
  • Develop enhanced risk assessment facilitation skills
  • Implement what they have learned through case studies

Contents

  • Quality Risk Management: an Overview (ICH Q9, ISO 31000 & PMI-RM)
  • Regulatory Expectation
  • How to realize Quality Risk Management in a GMP Environment
  • Applying Principles of QMR after an Incident has happened
  • How to apply Quality Risk Management in Validation
  • Design of an Event Handling System based on a Quality System and Quality Risk Management Approach
  • Presentation and Exercise on Risk Management in the Supply Chain
  • How to Implement Quality Risk Management in a Pharmaceutical Company

General Information

– Training materials will be distributed
– A Certificate of completion will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant

Gestion de la Qualité du Cannabis

La gestion de qualité au sein des entreprises est une activité cruciale qui a un impact sur l’efficacité,  la qualité, l’idendité, l’innocuité et la la pureté du cannabis. L’équipe de qualité est alors chargée de s’assurer que le système de qualité y compris tous les services sous-traités soient également vérifiés pour répondre aux normes de qualité fixées à la fois par l’entreprise et par les exigences réglementaires.

Objectifs

Cette formation, interactive et présentée en visioconférence, abordera le concept de bonnes pratiques de production (BPP) et de fabrication pharmaceutique (BPF), les exigences du système qualité, y compris les procédures opératoires normalisées (SOP), les plaintes, les rappels et les tests de laboratoire.

Contenus

  • Aperçu de l’historique du cannabis Sativa
  • Quelles sont les différentes réglementations appliquées à la production du cannabis
  • Éléments essentiels pour la culture du cannabis à des fins médicales
  • Méthodes de contrôle du cannabis
  • Pratiques : Manuel du système de la qualité
  • Méthodes de contrôle du cannabis
  • Contrôle et assurance qualité des produits du cannabis
  • Création et maintien d’un système de gestion de la qualité
  • Programme de sanitation et d’higiène, lutte contre la vermine
  • Amélioration grâce à la surveillance continue des processus
  • Rédaction Rapport aux agences de réglementation
  • Qualité du produit et atténuation des risques

Participants

Toutes les personnes qui travaillent dans les domaines de l’assurance et contrôle de la qualité, validation, Informatiques, concepteurs, intégrateurs, fournisseurs, affaires réglementaires et toute personne intéressée par les bonnes pratiques de production (BPP) du cannabis et les bonnes pratiques de fabrication (BPF).

À emporter

Matériels de formation, autres outils de support et Attestation de participation

Instructeur

Kossi Molley, Chimiste, LSSBB, Formateur agréé (CPMT) – Conseiller en gestion