18 May 2013

Features

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Features Quality and Compliance | 9 May 2013

Good Clinical Practice: Where Ethics and Quality Meet

This article discusses the history and primary principles of Good Clinical Practice (GCP), explaining that is much more than just a single document outlining the standards for clinical research. Read more »
Science and Technology | 30 April 2013

Mindfulness Training: A Means to Reduce Human Error

Minimizing or preventing mistakes is the linchpin of quality. It defines quality control in its strictest sense and is the key to maintaining an effective quality program. This article discusses the causes of human mistakes, mistake proofing and mindfulness training as a means to improve reading ability, working memory and task focus. Read more »
Under RAPS | 18 April 2013

RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation

Increasingly, regulatory professionals are involved in making organizational business decisions, yet few have formal business training. RAPS’ Executive Development Program was designed to help them hone their business, management and leadership skills. Read more »
Under RAPS | 4 April 2013

Helping to Lead the Regulatory Profession as a Leader, Mentor and RAPS Board Member

The Regulatory Affairs Professionals Society (RAPS) has, since its founding 1976, been the preeminent group representing regulatory affairs professionals involved in the regulation of healthcare products. With support from a dedicated professional staff, RAPS is led by 13 highly committed, distinguished and accomplished members of its board of directors.

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Regulatory Update

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EU’s Scientific Committees to Look at Synthetic Biology

Posted: 17 May 2013
The European Commission’s three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its Read more »

Corrected: CFDA Issues API Export Instructions to Provinces

Posted: 15 May 2013
China’s Food and Drug Administration (CFDA) last week issued instructions to Chinese provinces regarding the requirements for certifying active pharmaceutical ingredient manufacturers for the right to Read more »

TGA Opens Consultation on New-to-Market Communication Proposal

Posted: 14 May 2013
Australia's Therapeutic Goods Administration (TGA) has opened a consultation to seek views from interested parties on the value, feasibility, design and impacts of a proposed new-to-market risk Read more »

Brazilian House Holds Hearing on Anvisa Regulatory Authority

Posted: 13 May 2013
The Committee on Social Security and Family of Brazil’s House of Representatives held a hearing on 9 May 2013 on the scope of regulatory authority of Brazil’s National Health Surveillance Agency Read more »

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Regulatory Exchange

Join the discussion -- RAPS Regulatory Exchange

RE:FDA CFR Part 11
Posted: 5/17/2013 9:40:05 PM
From : Discussion Post>>Regulatory Open Forum
It is not an electronic record if you are printing the page and attaching it to the spreadsheet. Your spreadsheet is not subject to 21 CFR Part 11 (Electronic Signatures/Electronic Records). 21 CFR Part 111 (cGMP for Dietary Supplements) d...

RE:FDA CFR Part 11
Posted: 5/17/2013 8:42:20 PM
From : Discussion Post>>Regulatory Open Forum
If you are printing the documents from Excel and someone is reviewing those documents before they are filed, then you have a paper system. Yes, there is always a potential risk of data compromise using any type of electronic system, even as ...

RE:CAPA System
Posted: 5/17/2013 11:11:00 AM
From : Discussion Post>>Regulatory Open Forum
I'm a consultant (devices) and often advise my clients on this issue. I recommend that you don't set a specific time, because you will run into regulatory issues. Instead, recognize that that closure time, regardless of you define it, has ...

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