Charisma

#	Content
1	• Starting & Packaging Materials
2	• In-Process Controls & Quality Control
3	• Failed Batches
4	• Deviations & Non-conformances
5	• Process or Method Changes
6	• Marketing Authorisations
7	• Stability Monitoring
8	• Returns, Complaints & Recalls
9	• Past PQR Responses
10	• Equipment Qualification
11	• Contractual Agreements

#	Outcomes
	• Verification of the consistency and quality standards of raw materials, packaging materials, in-process parameters, and finished products.
	• Identification of quality/process defects, batch rejections, and out-of-specification parameters.
	• Determination of product stability trends, yield trends, and manufacturing parameters.
	• Assessment of the impact and effectiveness of Corrective and Preventive Actions (CAPA).
	• Pharmaceutical manufacturers and drug product license holders for markets such as the U.S. and Europe.
	• Regulatory authorities and Good Manufacturing Practice (GMP) compliance bodies.
	• Organizational units including Quality Control (QC) units responsible for drafting, reviewing, and approving production and process controls.

#	Participants
1	� • Verification of the consistency and quality standards of raw materials, packaging materials, in-process parameters, and finished products.
2	� • Identification of quality/process defects, batch rejections, and out-of-specification parameters.
3	� • Determination of product stability trends, yield trends, and manufacturing parameters.
4	� • Assessment of the impact and effectiveness of Corrective and Preventive Actions (CAPA).
5	� • Pharmaceutical manufacturers and drug product license holders for markets such as the U.S. and Europe.
6	� • Regulatory authorities and Good Manufacturing Practice (GMP) compliance bodies.
7	� • Organizational units including Quality Control (QC) units responsible for drafting, reviewing, and approving production and process controls.