The Data Integrity-Throughout product life cycle to ensure patient safety

The Data Integrity-Throughout product life cycle to ensure patient safety

Data Integrity is a fundamental element of a (Bio) pharmaceutical industry to ensure quality and safety of drugs. It’s a major global concern of health authorities and (Bio) Pharma companies. Although Data Integrity is not a new issue, it has gain alarming attention in last few years due to FDA’s and MHRA’s scrutiny and a number product detention, import alerts, suspension of marketing authorization and warning letter issued to companies found non-compliant.

Although Data integrity is a global issue it is a burning topic in Asia- Pacific, specifically China and India. According to Indian ministry, India has the second-largest number of manufacturing facilities outside of the US (523 as of March 2014) registered with the US FDA. Furthermore, India’s drug exports to the US have risen from US$1.25 billion in FY10 to US$3.45 billion in FY14.2. With the growing importance of the Indian pharmaceutical industry in the global market, the number of foreign regulatory inspections has also increased considerably.  DOWNLOAD OUR BROCHURE

KEY TOPICS 

• What is Data Integrity and why is it an Issue now?
• What is industry’s reaction to Data Integrity?
• What are the recent regulatory changes for Data Integrity?
• Role of Management- What should be the management structure for DI accountability
• What factors to consider before establishing a DI plan
• How is DI validated? - Is your company Inspection ready? Really?