Quality Management
Quality management is the set of all activities carried out in the realisation of a product or provision of a service as well as by the personnel engaged in the achievement of the objectives of the quality policy. The courses related to this subject area are applied in the field of Validation, Quality and Manufacturing.
For more information about our training write to academy@ptm-consulting.it.
Courses Available ON DEMAND:
The course will present what are quality audits and inspections (I, II, III level), deepening aspects of conducting and managing internal, external and regulatory inspections.
Basic training on change and deviations: what they are and how they must be managed.
Basic training on Good Manufacturing Practices: what they are and what they contain. Practical guide to EudraLex content - Volume 4 - Good Manufacturing Practice (GMP) guidelines.
The introduction of ICHQ3D before and the request of EMA and FDA to assess the presence of nitrosamines in drugs have put companies in a position to review the documentation of their products sometimes already on the market to ensure their quality and safety through the identification and assessment of the presence of unacceptable levels of impurities. A richio-based approach, as required by regulatory agencies, is a must, but not always simple to implement. The course presents how to manage and approach the management of impurities and how to maintain an up-to-date state of the relevant documentation.
Basic Clinical Good Practice Training: what they are and what they contain.
Basic training on Good Laboratory Practices: what they are and what they contain.
Documentation is an important aspect for the management of the process and the product in all its phases of the life cycle. This course aims to present the rules to prepare proper documentation (protocols, reports, SOPs, methods, training records, etc.) and how to set up its proper management.
Quality support - The production of sterile medicines according to Annex 1.
Basic training for a correct drafting and management of Manufacturing Bach Records.