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EduQuest, Washington DC
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A Global Team of FDA Compliance Experts based near Washington, DC
A Global Team of FDA Compliance Experts based near Washington, DC

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 Learn from former FDA investigators and policy-makers,
including the author of the original Part 11 rules,
as well as expert advisors who train and consult for global industry.
 
Receive expert advice from ex-FDA senior officials, former inspectors, and industry authorities.
 
Keep your company safe from FDA’s stepped-up enforcement in three areas directly impacted by Part 11 and computer systems validation:
 
1. Data integrity, especially in product manufacturing and clinical trials
2. Supplier quality assurance, including software vendors
3. Audit trails and change control in virtual computing environments, including “Software as Service” and cloud computing
 
This course also includes a complete update on FDA’s latest Part 11 “tag-along” inspection initiatives and a thorough explanation of the EU's Annex 11 rules and their relationship with Part 11.

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What's the best way to respond to FDA 483 inspection observations -- including ones you disagree with? Martin Browning -- EduQuest's president and former FDA field investigator and co-developer of FDA's Quality System Regulation -- offers you some practical advice here: 

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FDA Compliance Document of the Month: Correlation (Cross-Walk) between 21 CFR 820 and Best Practices in Design Controls

Download this free 76-page EduQuest Advisory for a detailed "cross-walk" connecting your requirements under FDA's 21 CFR Part 820 (the Quality System Regulation) to the best practices in Design Controls -- as recommended by EduQuest Vice President Denise Dion. Denise served 18 years as an expert FDA field investigator and was a member of FDA's Design Control Inspection Strategy Team.
 
Denise also is the developer and lead instructor of EduQuest's popular two-day Design Control for Medical Devices training class, scheduled November 11-12, 2015 near Baltimore and Washington, DC. In addition to explaining FDA's Design Control rules in every-day language, the class allows you to be part of a fictional product design team and identify Essential Design Inputs and Outputs; validate and verify product design; efficiently handle Design Changes; and effectively transfer product design to the manufacturing floor and your suppliers. 
http://www.eduquest.net/compliance%20library.htm
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Learn to understand and meet FDA's 21 CFR 820.30 rules for quality design and manufacturing.

Design control is required for all medical devices sold in the U.S., EU, Japan, and several other countries. In addition, there’s relentless pressure from both FDA and Congress to improve device design control and manufacturing.

By registering for this 16-hour Design Control course, you will:

* Learn how FDA expects you to develop, implement, and manage design control
* Focus on overcoming one of the biggest obstacles that confounds device companies – accurate and consistent transfer of product design to actual manufacturing operations
* Discover how FDA’s design control rules relate to product standards established in ISO 9001:2000 and ISO 13485

Your EduQuest instructor is a former FDA investigator and the founding editor and co-author of the FDA’s “bible” for inspectors, the Investigations Operation Manual (IOM). She also helped to develop FDA's Quality System Inspection Technique (QSIT) and served on FDA's Design Control Inspection Strategy team.

Tuition is $1,995. Attend this course plus the QSR Compliance Basics for $2,997 and save nearly $600 on the combined course tuition.

To register or get more details, call EduQuest at +1 (301) 874-6031 or visit http://www.eduquest.net/Design_Control_Training_Class.htm

This course -- like all EduQuest open enrollment courses -- is also available On-Demand, delivered when and where you want it just for your own company.

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√   Fully understand your company’s obligations to develop and maintain an effective Quality System under the 21 CFR 820 regulations
 
√   Learn straight from the source – former FDA inspectors, rule-makers, and trainers from the global consulting team of EduQuest
 
√   Get interactive, real-world classroom training on the essential FDA Quality System rules you must know to prepare for your next inspection or 3rd-party audit

Get interactive, real-world classroom training
on the essential FDA Quality System rules you must know.
 
The scope of FDA’s Quality Systems Regulation (QSR) is huge – more than 500 pages of rules and guidance – and non-compliance is not an option. Just within the past 18 months, more than two dozen medical device companies have received Warning Letters for deficient quality management programs, and several were threatened with removal of their products from the market.
 
Compliance with FDA’s Quality Systems approach is recognized globally as a pre-requisite not only for getting your product on the market but – just as importantly – keeping it there. This 2-day QSR Basics course walks you through the requirements of 21 CFR 820, discusses how FDA’s rules correlate with ISO standards and ICH guidance, and examines current FDA inspection and enforcement priorities.

Learn straight from the source – former FDA inspectors, rule-makers, and trainers from the global consulting team of EduQuest, headquartered near Washington, DC. Instructors include one of the co-authors and trainers of FDA’s Quality System Inspection Technique (QSIT) and the founding editor and co-author of FDA’s “bible” for inspectors, the Investigations Operations Manual (IOM).

Save with Extended Training -- Four-Day Device Compliance Learning Package:
Combine the QSR Compliance Basics course with the 16-hour Design Control for Medical Devices course (offered immediately afterwards, on Wednesday and Thursday).

Get the class agenda, instructor qualifications, and registration information from this link:
http://www.eduquest.net/QSR_Basics_Training_Class.htm

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This month marks EduQuest's 20th year of service to FDA-regulated companies. A big, big "thank you" to our training students and consulting clients who have allowed us to work with you and together make a safer and healthier world.

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What’s available from FDA to help you prepare for your next inspection? EduQuest VicePresident Denise Dion -- who was an expert FDA field investigator for 18 years -- shares her list of key resources here: 
http://eduquest-ions.com/whats-available-from-fda-to-help-prepare-for-your-next-inspection/
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Now online: 101 searchable, key-worded FDA compliance FAQs about Quality Systems, Auditing, Part 11 and Design Control -- all from the experts behind EduQuest-ions & Answers:

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FDA Expectations for Cloud Computing and SaaS Environments: Pharma and device manufacturers learn to do it right at EduQuest training class taught by the author of Part 11 and former FDA investigators.
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