Data Integrity in Pharmaceutical and Biotech Labs
Dr. Nanda Subbarao, Senior Consultant at Biologics Consulting Group
Coming soon.. Please contact customer care for new schedule
The subject of Data Integrity has become an increasing concern for Regulatory Agencies worldwide. We have seen a sharp increase in the number of Warning Letters by the FDA on this topic and the majority of the laboratory related warning letters issued in 2015 focused on this topic. The FDA has issued a draft guidance in April 2016 on Data Integrity which will have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived. This seminar addresses the key elements of Regulatory Expectations for Data Integrity. Ten steps to achieving an efficient and cGMP compliant Data System will be discussed..
Who will Benefit:
- QC chemists, supervisors and managers
- R&D chemists, supervisors and managers
- QA managers and personnel
- Regulatory affairs personnel
Seminar Fee Includes:
$100 Gift Cert for next seminar
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Introduction to regulatory expectations for data integrity.
- Consequences of not meeting regulatory expectations for data integrity
- A ten step approach to implementing an efficient and complaint Data System
- Generating, review and archiving GMP data
- How to address OOS results
- Data integrity and instrumentation
- LIMS systems
Meet Your Instructor
Senior Consultant, Biologics Consulting Group
Dr. Subbarao is currently a Senior Consultant with the Biologics Consulting Group, Inc specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She has been involved several times over her career in projects to setup new or upgrade existing cGMP/GLP Quality Systems for laboratory and stability programs during development and in commercial phase. She serves on the American Association of Pharmaceutical Sciences, Stability Focus team Steering Committee and serves on the editorial advisory board of Bioprocessing International
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Gateway of India
The Gateway of India is a monument built during the 20th century in Mumbai, Maharashtra. It is located on the waterfront in the Apollo Bunder area in South Mumbai and overlooks the Arabian Sea. The structure is a basalt arch, (85 feet high. It lies at the end of Chhatrapati Shivaji Marg at the water's edge in Mumbai Harbour. It was a crude jetty used by the fishing community which was later renovated and used as a landing place for British governors and other prominent people. In earlier times, it would have been the first structure that visitors arriving by boat in Mumbai would have seen. The Gateway has also been referred to as the Taj Mahal of Mumbai, and is the city's top tourist attraction.
Sanjay Gandhi National Park
Sanjay Gandhi National Park (SGNP), previously Borivali National Park, is a large protected area in the northern part of Mumbai city. It encompasses an area of 104 km2 and is surrounded on three sides by India's most populous city. It is notable as one of the major national parks existing within a metropolis limit and is one of the most visited parks in the world. The rich flora and fauna of Sanjay Gandhi National Park attracts more than 2 million visitors every year. Tourists also enjoy visiting the 2400-year-old Kanheri caves sculpted out of the rocky cliffs which lie within the park.
The Elephanta Caves are a network of sculpted caves located on Elephanta Island, or Gharapuri (literally "the city of caves") in Mumbai Harbour, 10 kilometres to the east of the city of Mumbai. The island, located on an arm of the Arabian Sea, consists of two groups of caves—the first is a large group of five Hindu caves, the second, a smaller group of two Buddhist caves. The Hindu caves contain rock cut stone sculptures, representing the Shaiva Hindu sect, dedicated to the Lord Shiva. The rock cut architecture of the caves has been dated to between the 5th and 8th centuries.
Chhatrapati Shivaji Maharaj Vastu Sangrahalaya
The Chhatrapati Shivaji Maharaj Vastu Sangrahalaya (CSMVS), formerly Prince of Wales Museum of Western India, is the main museum in Mumbai. It was found in the early years of the 20th century by prominent citizens of Mumbai, with the help of the government, to commemorate the visit of the then prince of Wales. It is located in the heart of South Mumbai near the Gateway of India. The museum was renamed in the 1990s or early 2000s after Shivaji, the founder of Maratha Empire. The building is built in the Indo-Saracenic style of architecture, incorporating elements of other styles of architecture like the Mughal, Maratha and Jain. The museum building is surrounded by a garden of palm trees and formal flower beds. It houses approximately 50,000 exhibits of ancient Indian history as well as objects from foreign lands, categorized primarily into three sections: Art, Archaeology and Natural History.
Nehru Science Centre
Nehru Science Center (NSC), Mumbai, is India's largest interactive science center, located in Worli. The center is named after India's first Prime Minister, Jawaharlal Nehru. In 1977, the center started with the 'Light and Sight' exhibition, and then in 1979 a Science Park was built. It is the largest science center in the country, and has a sprawling 8 acres of science park with varieties of plants, trees and shrubs. More than 500 hands-on and interactive science exhibits on energy, sound, kinematics, mechanics, transport, etc. are installed in the park. The NSC building, with its unique architecture, houses several permanent science expositions on various themes.