GMP News - Quality Assurance

09.11.11

Medical Devices Warning Letter Statistics 2011

The ECA provides the FDA Warning Letters Analysis on a regular basis. This news describes the development of the 2002 to 2011 Warning Letters Top Five list with regard to medical devices. The number of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) is…. read more.

02.11.11

First ECA/EQPA Conference in the U.S. a great Success

From 7-9 June 2011, the first joint conference of the European Compliance Academy and European QP Association was held in Bethesda, Maryland on European GMPs and the duties and responsibilities of the Qualified Persons according to the European regulations. Find out more.

26.10.11

FDA defines 25 SOP provisions required by CFR

The latest edition of the Federal Register shows a very good summary of SOPs required by 21 CFR Part 211. Read more.

26.10.11

FDA publishes List of Guidance Documents for Medical Devices

In early October the FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development in the fiscal year 2012 (October 2011- September 2012). Read more here.

20.10.11

FDA strives for more Transparency regarding GMP Compliance and Enforcement Data

The US Food and Drug Administration (FDA) has issued a report in which it proposes to make Compliance and Enforcement Information more accessible and user-friendly. The proposals are part of FDA's current efforts to make its operation and decision making more transparent. Read more.

05.10.11

EMA Reflection Paper provides Concrete Information about Risk based Quality Management

The "Reflection paper on risk based quality management in clinical trials" recently published by the EMA contains a table (Annex 1) which presents the points to consider for the risk identification, examples of how to control them and eventually mitigation and/or acceptance solutions. This gives interesting insights into EMA's specific positions about risk control. Read more here.

21.09.11

FDA criticises SOP Training in pharmaceutical Companies

Reviewing FDA's warning letters of the last fiscal year reveals that management and training of Standard Operating Procedures (SOPs) is still a hot topic. Read more.

07.09.11

European QP Association forms Expert Panels

After the first five successful years of its existence, the European Qualified Person Association (EQPA) decided to develop a new structure and to integrate more colleagues into its activities. Read more.

31.08.11

FDA Courses and Tests now available online

The organisation and the regulations of the US Food & Drug Administration (FDA) are frequently considered hard to comprehend. With regard to medical devices the CDRH runs a quite detailed website. Read more.

24.08.11

EU GMP Guide: New Requirements added for Batch Certification

In Part III of the EU GMP Guide, a document on internationally harmonised requirements for batch certification has been added. Read more.

24.08.11

FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications

End of July, the FDA published a draft on the documentation of medical device modifications. Read more about the 26 pages document here.

24.08.11

New WHO guidance for Storage and Transportation

WHO has published a model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products. Read more.

10.08.11

EU Product Quality Review now also part of WHO GMP main Principles

The WHO has incorparated a new section on "Product Quality Review" in its GMP Main Principles for Pharmaceutical Products. Read more.

10.08.11

FDA publishes SOP for "Notice to Industry" Letters for the Medical Devices Industry

The FDA Center for Devices and Radiological Health (CDRH) has published a SOP to describe how it will inform Medical Devices manufacturers about new or modified requirements/expectations by use of "Notices to Industry" Letters in the future. Read more.

03.08.11

New FDA Draft Guidance regarding Design Development of Medical Devices

Until 19 September 2011 you have the possibility to comment and maybe influence the new FDA Draft Guidance regarding Design Controls of Medical Devices. Read more here.

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GMP News - Quality Assurance

Medical Devices Warning Letter Statistics 2011

First ECA/EQPA Conference in the U.S. a great Success

FDA defines 25 SOP provisions required by CFR

FDA publishes List of Guidance Documents for Medical Devices

FDA strives for more Transparency regarding GMP Compliance and Enforcement Data

EMA Reflection Paper provides Concrete Information about Risk based Quality Management

FDA criticises SOP Training in pharmaceutical Companies

European QP Association forms Expert Panels

FDA Courses and Tests now available online

EU GMP Guide: New Requirements added for Batch Certification

FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications

New WHO guidance for Storage and Transportation

EU Product Quality Review now also part of WHO GMP main Principles

FDA publishes SOP for "Notice to Industry" Letters for the Medical Devices Industry

New FDA Draft Guidance regarding Design Development of Medical Devices

Recommended Event

The Validation Manager in the Pharmaceutical Industry - Live Online Training

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