Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of warning letters citing data integrity and the resulting number of import alerts. Company Quality Management Systems are being scrutinized as to how the integrity of raw data (both electronic and manual) generated in the Quality Control Laboratory and in Operations (Manufacturing and Engineering) can be assured. The FDA is now including recommendations for recipients to obtain 3rd party assistance when addressing DI issues. Indicators of potential Data Integrity issues are an unreasonably low number of deviations, OOS incidents and EM excursions. Regulatory non-compliance is always a serious area of concern for the Indian pharmaceutical sector. With 13 warning letters being issued in FY 2015 and 9 warning letters in FY 2016, Data Integrity still continues to be a severe problem to be tackled.
About the University
(University Established by M.P. Legislature Act No.44/2011 and Duly recognized by UGC u/s 2 (f)) “The university is dedicated to perform in unique manner to achieve the academic excellence in creative way by using the innovative ideas to produce competent human resources & to act as center for Amicable Knowledge Solution”. AKS (Amicable Knowledge Solutions) University was established in 2011 and located in the rural area of District Satna, spread over 70 acres of the land with beautiful landscape of ornament plants. The AKS University is focused on emerging as a leading institute of knowledge, research & consultancy in a number of faculties, namely Pharmaceutical Science & Technology, Engineering & Technology, Computer Application & IT and Science, Agriculture Science & Technology, Life Sciences & Biotechnology, Basic Science, Management Studies, Fine Arts and Design, Commerce and Financial Studies, Social Sciences & Humanities. Approximately 10000 students not only from different states of India but from neighboring countries (Nepal) are studying in various disciplines. Majority of them come from rural areas and shine well.
ABOUT COLLEGE INNOVATIVE GROUP OF INSTITUTIONS
Innovative Welfare and Education Society (Regd.) duly registered under the Society Registration Act 1860 on 9th February, 2004 took upon itself the onerous task of spreading literacy in the rural and urban areas in India.
Pharmacovigilance (PV) is a science relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. To track Adverse Drug Reactions (ADRs) in Indian Population, Ministry of Health & Family Welfare (MoHFW), Government of India, has launched Pharmacovigilance Programme of India (PvPI). This programme has a pan-India outreach, but only a small proportion of the healthcare professionals have formal training on PV. As per the recent amendments to Drugs & Cosmetics (D&C) Rules, 1945, the inclusion of PV in undergraduate pharmacy curriculum as per Pharmacy Council of India (PCI) notification and order from MoHFW to all states/UTs Government regarding strengthening of PV in particular states, the avenues in PV sector have widened and it has become now a priority area. As per the theme of Pradhan Mantri Kaushal Vikas Yojana, IPC has taken initiative for skill development and capacity building programme by imparting training to young healthcare professionals in the field of Pharmacovigilance.
The Council of Scientific & Industrial Research (CSIR) invites nominations for CSIR Young Scientist (YS) Awards for the year 2018. The awards are to be given for research contributions made primarily in India. The nominee should be a regular Scientist (as per CSRAP Rules) of CSIR system and should have joined the CSIR laboratory on or prior to 26th September 2017. The age of the nominee should not be more than 35 years as on 26th September 2017.
ANAND PHARMACY COLLEGE is one of the leading institute of Gujarat established in 1998 by Shri Ramkrishna Seva Mandal. The institute is conducting All India Council for Technical Education (AICTE), New Delhi approved courses since 1998. Anand Pharmacy College offers B.Pharm, M.Pharm in Pharmaceutics, Pharmacology, Pharmaceutical Quality Assurance, Industrial Pharmacy & Pharmaceutical Technology and Ph.D. courses. The institute is re-accredited by NAAC- UGC (Grade A with CGPA 3.06) and accredited by NBA (UG Course). The institute regularly invites learned and eminent entrepreneurs, academicians, industrialists and dignitaries to deliver lectures and create an environment of enthusiasm and zeal among students and staff members for educational excellence.
About the institution
Creative Educational Society was established in the year 2006 under the aegis of Creative Educational Society (CES), Kurnool. It was founded by a group of academicians and professionals to impart the value based professional education. The college is located at chinnatekur on Hyderabad-Bangalore national high way-7, it is located about 13 Km from Kurnool. The institute is offering Bachelor degree in Pharmacy, Pharm. D, Post Baccarat (PB), Master degree with specializations 1.Pharmaceutics 2. Pharmaceutical Analysis and Quality Assurance 3. Pharmaceutical Chemistry 4. Pharmacology and also has the University recognized Research Center to pursue Full time Ph.D affiliated to Jawaharlal Technical University Anantapur (J.N.T.U.A), approved by A.I.C.T.E, Pharmacy Council of India (P.C.I) and Recognized under section 2f & 12 b of UGC act.
The IIHMR University is a specialized Research University in management research, postgraduate education and training exclusively in the health sector.The University is ranked No. 1 B-School (Healthcare Sector) in Business World 2016. The University has been designated as a WHO collaborating Center for District Health Systems based on Primary Health Care.
ABOUT SPP SPTM
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM), established under the auspices of SVKM'S NMIMS in 2006 is a pharmacy school which offers Doctoral, Postgraduate, Graduate and Diploma Programs in Pharmaceutical Sciences. It pioneers in postgraduate and graduate courses integrated with Healthcare Management. The curricula designed by the school nurtures and develops young minds into responsible Pharma professionals who will contribute ethically to the future of Pharma Industry, Hospitals, Community, Society and Health-care system at large. SPPSPTM has received the presgious Category Award “Rajiv Gandhi National Quality Awards” in MSME Scale Service sector by the Bureau of Indian Standards, The National Standards Body of India, and Govt. of India.
About Parul Institute of Pharmacy
Parul Institute of Pharmacy was established in 2004. The institute is approved by the All India Council for Technical Education (AICTE) and Pharmacy Council of India (PCI), New Delhi and recognized by the Government of Gujarat. The institute was accredited by the National Assessment and Accreditation Council (NAAC) and the National Board of Accreditation (NBA), manifesting its commitment to provide quality teaching- learning and research. The institute is housed in sprawling lush green campus with an imposing building and most conducive atmosphere for academic excellence. The state-of-the-art infrastructure and instructional facilities of the institute includes well- equipped laboratories, voluminous library and spacious lecture halls. Parul Institute of Pharmacy is amongst the top ranking institutes in Gujarat. The Institute has grown impressively in both size and reputation and has become the preferred choice for many among all other self-financing institutes. At Parul Institute of Pharmacy, we provide our students with distinguished knowledge and top class facilities to meet the highest benchmarks. We have well experienced and learned faculty, scholastic curriculum, diverse educational exposure and various on-campus facilities which collectively focuses on all round learning experience and rewarding opportunities forthe students.