Current Practices in Aseptic Processing

Current Practices in Aseptic Processing

Upcoming Events
Online Live Training Current Practices in Aseptic Processing 22nd – 23rd October 2020 | 10:00 AM | 4 Hours (Each Day) Course Expert Mr. Hitendrakumar Shah A Quality-oriented professional with over 2 decades of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO, and Schedule-M Guidelines. Learn More Introduction: Aseptic processing is a technology where the product and it's components may be exposed to the processing environment and thus demands utmost care. The viable, non-viable and endotoxin contamination become grave concerns, if not handled properly in controlled environment. Best control is possible only by proper design of the facility, it's good maintenance & utilities, timely…
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Excel Spreadsheet Validation in a GXP environment

Excel Spreadsheet Validation in a GXP environment

Upcoming Events
Online Live Training Excel Spreadsheet Validation in a GXP environment 10th October 2020 | 10:00 AM | 2 Hours Course Expert Mr. Hitendrakumar Shah A Quality-oriented professional with over 2 decades of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO, and Schedule-M Guidelines. Learn More Introduction: Computers are being used in all organizations. Where the Microsoft word and excel documents are routinely used for GXP activities. When we are using a Microsoft Excel spreadsheet for GXP activities, it is essential to validate it. If the excel spreadsheet is not validated, it will lead to nonconformance for the organizations. This training will help all the…
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Cleaning Validation – Practical Implementation & Compliance Approach

Cleaning Validation – Practical Implementation & Compliance Approach

Past Events
Online Live Training Cleaning Validation – Practical Implementation & Compliance Approach 24th - 25th September 2020 | 10:00 AM | 6 Hours (Each Day) Course Expert Mr. Hitendrakumar Shah A Quality-oriented professional with over 2 decades of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO, and Schedule-M Guidelines. Learn More Introduction: As we all are aware that cross contamination is considered as critical because it is directly linked to the patient safety. This training will provide insight to the attendees for practical implementation of Cleaning Validation and Evaluate Cleaning Validation Philosophy of in line with regulatory requirements. This training course provides practical guidance on…
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Electronic data auditing techniques in GXP environment

Electronic data auditing techniques in GXP environment

Past Events
Online Live Training Electronic data auditing techniques in GXP environment 26th September 2020 | 10:00 AM | 3 Hours Course Expert Mr. Hitendrakumar Shah A Quality-oriented professional with over 2 decades of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO, and Schedule-M Guidelines. Learn More Introduction: Many organizations are moving towards automations and using computerized systems for GXP activities. As, the GXP activities are performed by computerized systems, it becomes important for inspectors to check the compliance with respect to the current regulatory norms. Hence, it becomes responsibility of pharmaceutical companies to ensure readiness of computerized system for inspection. This training will help all…
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