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This webinar will survey the recent regulatory findings concerning data integrity, establish the importance of data integrity to GMP compliance & compare the content of the data integrity guidance from FDA, MHRA, EMA, WHO, and PIC/S.
- Describe the importance of data integrity to GMP compliance }
- Discuss the impact of regulatory issues resulting from lack of data integrity }
- Identify major differences between several recently issued regulatory guidance }
- Identify the clauses of the NSF/IPEC/ANSI 363 excipient GMP Standard that require data integrity
Dale is the Global Director of Quality for the Silica Business Unit of Huber Engineered Materials and past chair of IPEC-Americas. He is responsible for quality systems, product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, India, Finland, and China. Dale has been performing risk assessments for over 20 years in both food and pharmaceutical ingredients. He has been a member of the EXCiPACT ™ Board and NSF Joint Committee on Pharmaceutical Excipients.
Prior to joining Huber, he was the Manager, Product Quality and Management Systems in the Office of Compliance and Ethics for the Archer Daniels Midland Company where he supported processing and business operations in the development and improvement of quality management systems to ensure sustainable quality, regulatory compliance, effective risk management, and customer satisfaction. While with ADM he supported excipients, bulk APIs, food ingredients, dietary supplement ingredients, biofuels, animal feeds, and specialty grains products.
He holds a Bachelor of Science degree from Davidson College in Chemistry and a Master of Science degree in Chemistry from North Carolina State University.
Ms. Skutnik-Wilkinson is currently with BIOGEN where she is responsible for Regulatory Intelligence and Pharmacopoeial Affairs (a role similar to her Pfizer role detailed here). Previously she was the Vice President of NSF Health Sciences Pharma-Biotech. Before that, she was the Director of Quality Strategy at Pfizer, and was responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues on a global scale. Janeen has over 22 years of experience and expertise in compendial activities, quality and regulatory policy. She also has held a variety of positions spanning from responsibilities in documentation, change control, analytical method validation, and product launch. Ms. Skutnik-Wilkinson earned a Bachelors of Science from the University of Connecticut in 1994. Ms. Skutnik-Wilkinson is Past-Chair of the International Pharmaceutical Excipients Federation (IPEC Fed). She is also past-Chair of IPEC-Americas and served as Chair of IPEC Compendial Review/Harmonization Workgroup (1999 – 2007). She sits on the ICH Assembly (formerly known as the steering committee) as a representative for IPEC Federation, and is also actively involved in PDA, PhRMA and BPOG.