Training Development
GMP Training
Welcome to our selection of GMP Training Courses for all levels within your organisation. Whether you are complying with EU, FDA or other Regulations, we have a GMP Training Course to suit. All our courses are delivered in-company and are tailored to your particular requirements and can include company specific information & examples.
All the topics listed under each course are suggested only and can be customized for you as the client. The number of people per session and the number of sessions per day are all agreed with you, the client, to ensure minimal disruption to operations.
Good Manufacturing Practice (GMP) for Management
These sessions are designed to ensure that Management, Supervisors and Professionals are aware of the latest regulatory requirements. Focusing on updates and trends, these sessions are designed to assure that staff responsible for compliance are aware of the most current expectations.
These session are short, informative and typically customised for the facility in which they are delivered. Case Studies and Breakout sessions can be included to enhance learning outcomes.
Root Cause Analysis Tools
Since the publication of ICH Q9, root cause analysis tools should be used as part of complaint, deviation and failure investigations. This half-day course is designed to overview some of the techniques that can be used, e.g. fish bone diagrams, the 5 why, process mapping and more…
Good Control Laboratory Practice (GCLP)
This course is aimed at analysts in the QC laboratory. Compliance in the laboratory is a critical, but varied area. The topics that can be covered are so numerous, that you are free to choose! ‘Hot topics’ such as Root Cause Analysis Tools for OOS investigations are included.
Good Manufacturing Practice (GMP) for Materials Management
The potential for counterfeit materials is currently one of the ‘HOT TOPICS’ in the business. This course is aimed at reviewing the GMP basics with materials management, warehouse or logistics personnel to assure Supply Chain Confidence – exploring all areas from purchasing to shipping. The course can be delivered as a unit or divided out into relevant modules for each department.
GMP expectation for the External Supply Chain
This course details the GMP expectations in relation to managing Outsourced activity. Looking at the entire Supply Chain from materials to distribution, this course ensures that personnel are aware of responsibilities in this area. This course can be customized to a particular supply chain and global markets
Auditing for GMP
Periodically auditing for GMP compliance is a regulatory requirement. This not only requires a thorough understanding of the regulations, but also an insight into how they are being applied. Do you auditors know how to keep current with what is being found in regulatory inspections? It is essential that auditors understand these requirements and the importance of the function that they perform. Many inexperienced auditors have difficulty establishing when an issue is an issue and the appropriate corrective action required. We take people through the skills required to prepare, conduct and report on Internal Inspections, so that the inspections are value added and help avoid regulatory issues for the company.
Cleaning Validation
Designed in response to the updated requirements, designed to ensure that all personnel involved in performing, sampling, testing, and approving cleaning validation protocols understand the process and current expectations.
Quality Systems Design & Implementation
Our consultants are experienced in the design and implementation of quality systems for deviations, complaints, CAPA and change control. Our competence is based on actual cases with both multi-national and national clients