Charisma

#	Content
1	Module 1: Introduction to In-Process Controls
2	Module 2: Regulatory Requirements
3	Module 3: Critical Process Parameters (CPPs) and Critical
4	Module 4: Sampling for In-Process Controls
5	Module 5: In-Process Testing and Monitoring
6	Module 6: Acceptance Criteria and Decision-Making
7	Module 7: Statistical Process Control (SPC)
8	Module 8: Documentation and Record Keeping
9	Module 9: Handling Deviations and Out-of-Limit Results
10	Module 10: Equipment and Measurement Systems
11	Module 11: Audits and Inspection Readiness
12	Module 12: Practical Workshops and Case Studies

#	Outcomes
	• Understand the principles and importance of In-Process Controls (IPC) in manufacturing.
	• Apply GMP requirements related to in-process monitoring and testing.
	• Identify critical process parameters (CPPs) and critical quality attributes (CQAs).
	• Perform in-process inspections, sampling, and testing according to approved procedures.
	• Interpret IPC results and determine compliance with acceptance criteria.
	• Detect process deviations and initiate appropriate corrective actions.
	• Maintain accurate IPC documentation in accordance with Good Documentation Practices (GDP).
	• Utilize statistical tools for process monitoring and trend analysis.
	• Support product quality, process consistency, and regulatory compliance.
	• Prepare for audits and regulatory inspections related to production controls.

#	Participants
1	� • Production Operators and Technicians
2	� • Production Supervisors and Managers
3	� • Quality Control (QC) Analysts
4	� • Quality Assurance (QA) personnel
5	� • Manufacturing Engineers
6	� • Process Engineers
7	� • Validation Specialists
8	� • Laboratory Personnel
9	� • Packaging Supervisors
10	� • Engineering and Maintenance personnel
11	� • Regulatory Affairs professionals
12	� • Internal Auditors
13	� • Pharmaceutical, Biotechnology, Medical Device, Food, Cosmetics, and Chemical industry professionals
14	� • Anyone involved in manufacturing quality control or process monitoring