The workshop is for supervisory and middle level managers in manufacturing, quality and regulatory functions in industry and CDSCO nominees
The United States Food and Drug Administration’s (USFDA) India Office, the Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the Government of India’s Central Drugs Standards Control Organization (CDSCO) in association with Indian Pharmaceutical Alliance (IPA) will conduct Advanced GMP Workshops 2017 across four cities in India. The workshops will be held in Chandigarh (November 6-7, 2017); Ahmedabad (November 9-10, 2017); Goa (November 13-14, 2017); Hyderabad (November 16-17, 2017). The workshop will be held in collaboration with FDA, MHRA, EMA and CDSCO.
On day one, discussions will be held on quality systems, introduction to data reliability, regulatory expectations for data collection, storage, validation and verifications and data validation. Day two of the workshop will have discussions on data quality and integrity investigation in labs, data quality and integrity investigations in manufacturing and documentation practices, current trends in data quality and integrity issues in inspections and risk-based approach to investigations and what is industry doing and needs to do?
The workshop is for supervisory and middle level managers in manufacturing, quality and regulatory functions in industry and CDSCO nominees.
Speakers, who will take part in the workshop are:
Dr Carmelo Rosa, Thomas Arista and Dr Ademola Daramola from the US FDA; Mark Birse (Chandigarh and Ahmedabad) and Richard Andrews (Goa and Hyderabad) from MHRA and Dr Patrick Costello from EMA.