This webinar will survey the recent regulatory findings concerning data integrity, establish the importance of data integrity to GMP compliance and compare the content of the data integrity guidance from FDA, MHRA, EMA, WHO, and PIC/S.
Ideal for individuals involved with Regulatory Compliance, Quality Assurance, Quality Control, Production who have an appreciation of good documentation practices and GMP records and documents.
After attending this webinar, you will be able to:
- Define data integrity and establish its importance to GMP compliance
- List and describe recent data integrity issues found by FDA
- Summarize the content of each regulatory guidance
Dr. Irwin B. Silverstein. Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration.