About the Webinar
Data has always been important in pharmaceutical manufacturing and research. Data shall be always accurate and reliable to ensure the safety, efficacy and quality of a product. Data integrity is crucial to guarantee trust between the industry, customer and regulatory agencies. Data integrity-related cGMP violations have led to several regulatory actions. This webinar will focus on case studies associated with data integrity which will include difficulties and hurdles faced during data integrity systems implementation, actions taken and success stories. The focus of the webinar will be
Risk management approach to overcome data integrity risks.
Data governance framework and quality culture of an organisation.
Regulatory requirements & citations by different regulatory agencies and how to prevent such observations.
About the Presenter
Mr. VIPUL DOSHI is an accomplished Pharmaceutical professional serving the Pharmaceutical Industry from more than three decades. He has been leading the Quality and Regulatory affairs function in the Pharmaceutical Companies of high credentials .Throughout his career he has been providing passionate global leadership and pioneered in guiding the company to meet the Global Regulatory ,Quality Standards and Compliance requirements .He has been a leading advocate for Global Competitiveness and instrumental in due diligence for various acquisitions and mergers . He Possesses great expertise in Projects and Engineering for developing Infrastructures for APIs and Drug Products (Sterile and Non Sterile).He is actively involved with various professional associations like ISPE/PDA/AAM.
Contributing In various Roles and increasing responsibilities he is Currently President - Group Quality Assurance and Regulatory at Cadila Healthcare limited (Company has headquarters at Ahmedabad) . He also Leads Research and Development functions for Active Pharmaceutical Ingredient Environment Health & Safety and Pharmacovigilance.