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July 2016

 

 

academics

 

Clinical research courses

iBio, Inc. a leading provider of plant-based biotechnology for developing and manufacturing biological products, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to iBio's investigational biotherapeutic product, iBio-CFB03, for the treatment of systemic sclerosis.

Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD).

A REVIEW ON USFDA WARNING LETTER AND VIOLATION OBSERVED IN PHARMACEUTICAL INDUSTRY

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ABOUT AUTHORS
Suleman S. khoja 1, Sohil S khoja
1,Parthkumar H chauhan 2,Farhad S Khoja
1Resource person in pharmaceutical quality assurance ,VAPI, Gujarat.
2Resource person in quality assurance ,NAVSARI, Gujarat.
3Registered Pharmacist ,VAPI, Gujarat.
premukhoja@gmail.com

ABSTRACT
A review on USFDA observation and finding while inspection of Pharmaceutical the present review provide some important , Significant observation and measure of compliance.USFDA is an regulatory body governing health products which are made ( in or  outside USA) and marketed in united States of America. Significant deviation from cGMP and Significant violation from cGMP for both API Facility and formulations .strictly compliance requirements under 21 Code of federal regulations (CFR). FDA observation includes but not limited to this. If not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the Safety, Identity, Strength, Purity and Quality of drug product (SISPQ) ,violation under [ 21 CFR & 211.67 (a) ]. Data integrity is main issue Raised in most FDA warning letter. Corrective action and plan. Level of control must be raised from raw material, packaging material (Accurate, Legible, Contamptarious, Original, Attributable (ALCOA)) in process, finished dosage form, Maintain log book properly. Guidelines for Out of specification(OOS ) and out of trends(OOT)  must be follow if any required.

Submitted by admin on 13 July 2016

There are mutliple opening at Inventiv Health, Pune

 

- GSPV Associate I

Years of exp. 1-2 years

-GSPV Associate II

Years of exp 2-4

 

Walkin - 16-Jul-2016
 

Jobs in Pharmacovigilance

Made Easy with

Pharmacovigilance – A classical series of interview editions -1.0

Key features:

Submitted by admin on 13 July 2016
Forums

Jobs in Pharmacovigilance

Made Easy with

Pharmacovigilance – A classical series of interview editions -1.0

Key features:

Brief and well organized basics and advanced concepts of pharmacovigilance

All pharmacovigilance related regulations such as ICH, GVP etc.

Applications are invited for Pharmacist, Staff Nurse at IPHB

Applications are invited by the Director/Dean, I.P.H.B., Bambolim-Goa for recruitment to the following posts in this Institute from the suitable candidates. They should clearly indicate their name, address, nationality, date of birth, experience, employment registration number, 15 years of residence certificate in Goa and other essential certificates issued by the competent authority. The application should be accompanied with attested copies of the relevant documents to reach in the office of the Director/Dean, Institute of Psychiatry & Human Behaviour, Opp. Holy Shrine of Holy Cross, Bambolim - Goa on or before 20/07/2016.

Post : Staff Nurse, Pharmacist

Working opportunity for Pharmacist in Sahyadri Hospitals, Pune | 02 Posts

Sahyadri Hospitals is the largest chain of hospitals in Mahrashtra. It is always within easy reach due to its strategic locations which include cities like Pune, Nashik, Karad and Navi Mumbai.
Sahyadri group has 10 Hospitals with more than 860 beds currently and plans to expand to almost 1200 beds by end of the next financial year. Sahyadri has touched the lives of over 10 lakh people by providing quality care.

vacancy as Assistant Professors in Shri Ram College of Pharmacy

ShriRam College of pharmacy (SRCP) has been established by "Dayal Seva Evam Shiksha Samiti, Morena" in 2003, with the view to provide excellence in pharmacy education and to create an environment for blooming of pharmacy professionals. ShriRam College of Pharmacy is a part of the Shriram Group of Colleges comprising of Shriram College of Engineering and Management and SRIIT. The parent institute, established in 1998 and the  Pharmacy college is nurtured with care under the protective umbrella of the Dayal Seva Evam Shiksha Samiti.

Novartis looking for Health Registration Executive

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Health Registration Executive

Applications are invited for Professors, Associate Professors & Assistant Professors at Baddi University

Baddi University of Emerging Sciences and Technologies, formerly the Institute of Engineering and Emerging Technologies, is a private technical and professional higher education institution located at Baddi, Himachal Pradesh, India.

Applications are invited for the following positions for UG/PG Courses

Post : Professors, Associate Professors & Assistant Professors