Overview of ISO 19011:2018 Guidelines for Auditing Management Systems
06/11/2018 10:42
Overview of ISO 19011:2018 Guidelines for Auditing Management Systems
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FDA publishes revised MAPP, ANDA Suitability Petitions (5240.5)
10/08/2018 23:17
Today, August 10, 2018, the FDA published a revision to the Manualof Policies and Procedures (MAPP 5240.5), " ANDA Suitability Petitions."This MAPP establishes the policies and procedures for respondingto a suitability petition submitted to the FDA Office of Generic Drugs by or onbehalf of...
FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy
10/08/2018 23:13
FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancyTheU.S. Food and Drug Administration permitted marketing of the first mobilemedical application (app) that can be used as a method of contraception toprevent pregnancy. The app, called Natural Cycles,...
Brexit preparedness: EMA to further temporarily scale back and suspend activities
08/08/2018 23:59
Next phase of business continuity plan aimed at securing essential public and animal health activitiesThe European Medicines Agency (EMA) will launch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core...
FDA Launches New Medication Guide Database - Drug Information Update
08/08/2018 23:46
FDA has launched a new Medication Guide database to replace the current Medication Guide web page. Medication guides are provided with many prescription medicines. A Medication Guide is a form of patient labeling that is part of the FDA-approved prescription drug labeling. Medication Guides address...
FDA issues final guidance entitled Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
08/08/2018 23:38
Today FDA published a guidance for industry entitled Dissolution Testing and Acceptance Criteria forImmediate-Release Solid Oral Dosage Form Drug Products Containing HighSolubility Drug Substances. This guidance has been developed toprovide manufacturers with recommendations for...
Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products
05/08/2018 00:06
Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products
Seetharam Kandarpa Receives ASQ-Certified Manager of Quality/Organizational Excellence
24/05/2018 22:18
Milwaukee, Wis., 09/12/2017 — The Certification Board of ASQ is pleased to announce that Seetharam
Kandarpa has completed the requirements to be named an ASQ-Certified Manager of Quality/Organizational
Excellence, or ASQ CMQ/OE.
As such, Seetharam Kandarpa has reached a significant level of...
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24/05/2018 21:39
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Web Series 2 of ASQ CQA Mentoring Class: Auditing Fundamentals on 30 July 2017
23/07/2017 18:46
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