Course Content

Personnel

• Rules regulations and disciplines

• Gowning

• Garment Selection

• Qualification of personnel

• Training

Cleaning and Sanitization

• Supplies

• Disinfectants

• Cleaning agents

• Techniques

• Frequency

• Testing

 Environmental Monitoring

• Validation

• Routine monitoring  - selection of sites

• Air, particle, surface monitoring

• Personnel monitoring

• New standards

 Process Controls

• Media fills – initial validation

• Personnel qualification

• Re-qualification

• Sterility testing

Investigations and CAPAs

• Risk analysis

• Causes

• Investigation techniques

• Case studies