EMA & FDA Expectations in Aseptic Processing

About the Webinar
In an aseptic process, the drug product, container, and closure are first subjected to sterilisation methods separately, as appropriate, and then brought together. Because there is no process to sterilize the product in its final container, GMP compliance is critical for patient safety. In this webinar Vipul Doshi -Chief Quality and Compliance Officer at Zydus Cadila will discuss GMP compliance in Aseptic Processing – What the EMA & FDA Expects.
About Vipul Doshi :
Mr. Vipul Doshi has been in pharmaceutical Industry from more than three decades with diverse leadership and operational expertise across development, manufacturing, R&D, GXP quality assurance (QA) and manufacturing operations (parenterals, solid dosage forms, biotechnology, transdermal, biologics and vaccines).

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 companies to meet the Global Regulatory, Quality Standards and Compliance requirements.

He has been a Great Contributor in developing and implementing Quality attributes and Culture of Excellence based upon a set of core values and ethical practices, which integrate and improve business operations and enhance the compliance within the Organization.

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 has been actively involved with various professional associations like ISPE/PDA/AAM. Associated with varied Roles and increasing responsibilities he is currently Chief Quality & Compliance Officer at Cadila Healthcare limited (Company has headquarters at Ahmedabad). He also Leads IRA, Research and Development functions forAPI , Environment Health & Safety and Pharmacovigilance.