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

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

Practical HACCP for Drug and Food Safety

This 4-hour interactive online workshop will enable participants to develop practical knowledge of the principles of HACCP for Drug and food including principles of quality risk management and guidance on Good Hygiene Practices and Application of the HACCP System as per CODEX Recommended International Code of Practice General Principles of Food Hygiene 2020.

Objectives

The workshop provides instruction on how to implement a HACCP system in combination with Quality risk management from preliminary steps to documenting drug and Food Safety Plan with CCPs and Preventive Controls. Due to popular demand a section on How the FSMA affects HACCP – Hazard Identification, Evaluation and Preventive Controls is now included.

Contents

  • Introduction to Quality Risk Management
  • Basic Good Manufacturing practices
  • Personnel Practices Program
  • Sanitation Program
  • Types of Contamination and Contamination Control Strategy 
  • Principles of Hazard Analysis and Critical Control Point (HACCP) process
  • The preliminary tasks and principles of HACCP
  • Practical HACCP program development, implementation and maintenance
  • Identification and control of food safety hazards
  • Relationship between HACCP, food safety, Drug safety and GMP
  • The application of HACCP in legislation and Food Safety Standards
  • The benefits of HACCP
  • Training Program

Who should attend?

The training is suitable for food and drug handlers, supervisors, managers and HACCP team members working in food and drug industries.

General Information

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

Speaker

Kossi Molley, Chemist, LSSBB, Chartered Trainer – Managing Consultant

Digital & Computerized System Validation

The V-model has become a standard worldwide methodology for the validation of digital and computerized systems. Regulatory requirements, as well as industry guidelines, like GAMP®5, are orientated towards this model. But in Digital Transformation world, the validation execution should follow the principles of Quality and Data Integrity by Design which should call for Validation by design (Validation 4.0).

Objectives

As a specialist for the validation of digital and computerized systems, this Live Online Training will provide you with:

  • Suggestions on how current regulatory guidance on cloud computing and computerized systems relating to data integrity, critical thinking and Computer Software Assurance can be put into practice
  • Approaches and principles of Validation 4.0 and Validation by design
  • Real-life examples of how validation effort can be scaled according to risk-based approaches
  • Cloud Infrastructure risk evaluation and qualification
  • Answers to specific questions, e.g. on source code review or on creating specification documents
  • The opportunity to bring questions from your own practice up for discussion

Contents

  • Current Challenges and Evolution for CSV Activities
  • Health Canada GUI-0050, GAMP®5, 21 CFR Part 11, EU Annex 11, Data Integrity
  • Roles, Responsibilities and Governance
  • IT System Validation Lifecycle implementation and management
  • Scalability of Validation Activities
  • System, Process & Requirements Risk Assessment
  • Writing Requirements Documents
  • Requirements: The Good, the Bad and the Ugly
  • Effective Content of a CSV SOP
  • Data Integrity and Record Management
  • Design Review – How to Apply Critical Thinking
  • Bringing Legacy Systems into Compliance

Attendees

The Master Class is directed at employees from:

  • IT
  • Production
  • Engineering
  • Quality Assurance
  • Quality Control

Participants should already have gained experience in the validation of computerized systems, and preferably will have also attended a basic CSV Course.

General Information

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

Speaker

Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant

Risk-based Continued Process Verification

Objectives:

The third phase of the process validation life cycle, continued process verification, is the ongoing assurance that the routine process remains in a state of control. When product knowledge and process understanding are gained through Stage 3, the expectation is to use that information immediately for continuous improvement actions. This stage 3 “Continued Process Verification” is a new step in validation. Also legacy process should be (re)validated regarding this life cycle. The start is stage 3 “Continued Process Verification”.

This session addresses the concepts, methods and tools (e.g. Lean Six Sigma and QRM) used in ongoing/continued process verification (CPV).

Content

This Validation Masterclass will provide some answers to the following questions:

  • FDA and EMA Guidance regarding Process Validation and Continued Process Verification
  • How to Build Blocks of QbD – Design Space, Process Control and Assessing Risk
  • How to define Process Control Strategy – Stability and Capability Methods
  • How to apply Quality Risk Management to Continued Process Verification
  • How to implement Continued/Ongoing Process Verification in the routine production – beginning from the definition of the control strategy to the Product Quality Review /Annual Product Review?
  • What is state of the art regarding systems for detecting unplanned departures from the process?
  • How to handle the monitoring at Stage 3 (Continued/Ongoing Process Verification)?
  • How to deploy Lean Six Sigma tools to monitor and control Ongoing Manufacturing Process
  • What are the differences between Continued Process Verification (FDA), Continuous Process Verification (ICH Q8) and Ongoing Process Verification (EU) ?
  • Are there parallels regarding Medical Devices?
  • What statistic parameters could help?
  • Is a statistician necessary?
  • How is OPV/CPV linked to PQR/APR?
  • What are the expectations of the Regulatory Bodies (FDA, EU, MHRA, TGA, Health Canada, etc) ?

Attendees

  • Manufacturing Managers and personnel
  • Department managers
  • Research and Development Scientists
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Process and Manufacturing Engineers
  • Quality Assurance Personnel
  • Anyone with a desire to learn the fundamentals of methodical performance improvement

General Information

– Participants will receive a copy of the presentation(s), relevant notes and Master Class materials.
– A certificate of completion will be issued to participants.

Speaker

Kossi Molley, Chemist, LSSBB, Chartered Trainer – Managing Consultant