This training course will help you define the concepts behind the application of the Quality Systems (QS) to drug operations and the specific elements as discussed in the FDA guideline: Management Responsibilities, Resources, Manufacturing Operations and Evaluation Activities. The requirements in the ICH Q10 guideline and a comparison to the FDA document will also be discussed. You will learn how to conduct a Gap Analysis to determine your level of compliance and the recommendations for implementation of remedial and permanent actions to address any gaps found.
The training course will include specific discussion on each QS element from a risk-based approach so that the specific requirements can be prioritized based on the highest impact to product quality and this prioritization scheme can be applied during the implementation. The specific requirements to be addressed include: CAPA, internal audits, outsourcing management, risk management, knowledge management and change control. As a result, an effective plan for compliance can be developed and executed.