This workshop provides up to date knowledge of the key documents, documentation and record keeping required for pharmaceutical development and manufacturing processes. We cover all documentation elements of the manufacturing and controls sections of a regulatory dossier including processes development. The course provides a practical approach to master formula, batch records, laboratory controls and validation requirements for manufacturing processes and analytical method validation. Documentation requirements for the qualification of instrumentation and equipment (IQ/OQ/and PQ) are also introduced including validation protocols and validation reports.

The course comprises a carefully prepared balance of lectures, case studies, and hands-on document review and preparation.

By the end of this course you will: Recognise and understand the key documents involved in Chemical and Manufacturing Control (CMC) processes. Understand the role of these key documents in the Quality Management System. Understand how product specifications are determined. Understand the documentation requirements with regards to storage of materials, sampling procedures and qualification and training of personnel Know the key documents associated with laboratory controls Understand the process of selecting appropriate validation parameters for analytical method qualification (validation, verification and transfer) Understand the process of equipment and instrument qualification (IQ/OQ/PQ)