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Are Active Pharmaceutical Ingredient Manufacturers Compliant With New FDA GMP Guidance?
December 10, 2016In September, the FDA published Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients to provide AP...
Is Your Medical Device Compliant With The Second Draft Of The WHO Global Model Regulatory Framework?
November 01, 2016In mid-2016, the World Health Organization (WHO) published the 2nd draft of Global Model Regulatory Framework for Medica...
23 Data Integrity FAQs Answered By The EMA
September 22, 2016Last month, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group publ...
New from PIC/S: Draft Guidance on Data Integrity
September 10, 2016Earlier this year, the FDA published draft guidance on Data Integrity and Compliance for GMP. And now PIC/S has publishe...
Are you complying with the new FDA General Wellness Policy for Low Risk Devices?
August 19, 2016In July 2016, the FDA released Guidance for Industry and FDA Staff – General Wellness: Policy for Low-Risk Devices to cl...
Are You Following the FDA Medical Device Cybersecurity Guidance?
February 18, 2016In January the FDA published draft cybersecurity recommendations for marketed medical devices to protect patient safety....
Are you ready for the FDA guidance on the design of Interoperable Medical Devices?
February 11, 2016If your electronic medical device exchanges data with other devices, you need to read the new draft guidance just publis...
Are you complying with the European Commission's new version of Annex 16?
November 23, 2015In October, a new version of Annex 16 was published due to significant changes in the globalization of pharmaceutical su...
What do you need to know about the new FDA guidance on Manufacturing Site Changes?
November 16, 2015Recently, the FDA drafted this guidance document to help the medical device industry make decisions around manufacturing...
Are you prepared for WHO draft guidance on Good Data and Record Management Practices?
October 05, 2015In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integr...