CA-PA Management
CORRECTION :In the first instance, correction or remedial action focuses on the immediate situation in order to eliminate an existing non-conformance or undesirable situation.
CORRECTIVE ACTION: A Corrective Action is a reaction to a nonconformity or undesirable situation that
has already happened
PREVENTIVE ACTION: A Preventive Action is a proactive approach and process for detecting non-conformances or undesirable situations that have not yet happened and prevents them before occurring.
CAPA methodology should result in product and process improvements and enhanced product and process understanding.
References:
1. Q10 Pharmaceutical Quality System , [ Ссылка ]
2. CAPA within the Pharmaceutical
Quality System, [ Ссылка ]
3. WHO Deviation Handling and Quality Risk Management (draft) [ Ссылка ]
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
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