Persons charged with responsibility for product quality and/or GMP compliance must be able to execute their legal and ethical obligations. They can only do this if they understand the regulatory environment and the intent and requirements of the Code of Good Manufacturing Practices. Our experts helps to ensure the entire product life cycle for a company is compliant to relevant regulatory bodies. With experience in compliance, our experts assisted manufacturers with less regulatory oversight (such as Complementary medicinal products) bring in best practices to ensure that they too can become operationally efficient.
Introduction to GMP
This 2-day introductory course has been designed to provide personnel new to the pharmaceutical industry with a good understanding of GMP and Quality System requirements. It will also apply to experienced staff looking for a refresher, or existing companies that require a new TGA licence, e.g. 3rd party logistics providers that repack/reprocess.
Our GMP trainers will step through each chapter and common appendix of the Code of GMP for Medicinal Products and, using case studies and examples drawn from their own industry and consulting experience, will explain the requirements and how they are applied in different manufacturing environments.
The focus will be on ensuring product quality, and the prevention of adulteration and misbranding.
Applying Pharmaceutical Risk Management
Quality Risk Management is now at the cutting edge of the Life Sciences industry internationally. Recently, the ICH Q9 Guideline on Quality Risk Management (QRM) was incorporated as GMP Annex 20 by the MHRA, PIC/S and the EMEA. GMP Annex 11 is also currently under revision to include a clear reference to a risk-based approach for determining the level of validation.
Regulators expect that pharmaceutical professionals use risk management techniques and tools to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. SeerPharma presents this highly interactive, hands on course on how to apply risk management principles and tools.
Good Aseptic Practices and Sterile Products
This subject is designed to facilitate the development of knowledge and practical skills in the assessment of special risks associated with the manufacture of sterile pharmaceuticals and to develop and evaluate strategies and plans that will ensure acceptable sterility assurance levels.
The course is relevant to cleanroom and aseptic managers and supervisors as well as other staff with good aseptic practices responsibilities.