Navigation Links
FDAnews Announces: Data Integrity: The Key to FDA and GMP Compliance, Dec. 5-6, 2017, Arlington, VA
Date:9/26/2017

Data Integrity:
The Key to FDA and GMP Compliance
** Presented by FDAnews and Cerulean Associates LLC **
Dec. 5-6, 2017 – Arlington, VA
http://www.fdanews.com/fdadataintegrity

Consider this situation. The FDA gives simple instructions to its investigators: “If initial findings indicate the firm’s electronic records may not be trustworthy and reliable … a more detailed evaluation may be warranted.”

That's the polite way of saying this is when drug or devicemakers can expect to receive a warning letter.

With the increased scrutiny on data integrity, establishing internal competency and assessment programs is essential.

Join award-winning FDA compliance expert, author and Cerulean founder John Avellanet for Data Integrity: The Key to FDA and GMP Compliance workshop. He is recognized globally for his business-savvy pragmatic advice and engaging speaking style.

During the 10 workshop sessions, attendees will:

  • Identify likely risks and select the most appropriate controls
  • Review case study validation tests to see if data integrity is actually being verified
  • Draft a memo to be sent out by the senior team to all company employees about good data integrity
  • Draft a business case and plan for implementing a data integrity control framework
  • and more

After two days of 'total immersion' study, attendees will return to their office with increased understanding based on team exercises and case studies with informative, detailed explanations and honest no-holds-barred discussions with John Avellanet and fellow attendees.

Meet the Presenter:
John Avellanet, Founder Cerulean Associates LLC

John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society.

Conference Details
Data Integrity:
The Key to FDA and GMP Compliance
**Presented by FDAnews and Cerulean Associates LLC **
Dec. 5-6, 2017 – Arlington, VA
http://www.fdanews.com/fdadataintegrity

Tuition:
Early Bird Pricing: $1,597 (available until Nov. 3, 2017)
Regular Pricing: $1,797 (after Nov. 3, 2017)
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/fdadataintegrity
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/dataintegrity/prweb14729026.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
2. FDAnews Management Report: Implementing Risk-Based Verification and Validation
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
4. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
5. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
6. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
7. FDAnews Announces — New Job Board Now Available on FDAnews.com
8. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
9. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
10. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
11. FDAnews Announces — What to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/16/2018)... ... November 16, 2018 , ... Author and thought ... Science Transformed the Art of Medicine (GreenLeaf Press, 2018) was recently awarded a ... , Interweaving moving personal patient stories with a historical overview that reveals ...
(Date:11/16/2018)... ... November 16, 2018 , ... ... for the Grand Forks and Williston regions today. Dispensary Permits, a nationally recognized ... doing business as Strive Life in Grand Forks, North Dakota. , A total ...
(Date:11/16/2018)... ... 2018 , ... OnlineMasters.com, a trusted source for unbiased college ... physician assistant programs in the United States. The top-ranked programs were selected based ... graduate schools across the country with only the top 10 making it to ...
(Date:11/15/2018)... ... November 15, 2018 , ... November 13, ... platelet-rich plasma (PRP) therapies to her leading selection of minimally-invasive aesthetic treatments. PRP ... all-natural revitalization for any area of the body. Atagi Plastic Surgery & Skin ...
(Date:11/15/2018)... ... , ... Sift Healthcare, a revenue cycle intelligence company, has ... Wind River Financial, a Madison-based payment processing company. , The company, formerly ... a range of solutions for healthcare organizations including claims workflow intelligence, reimbursement performance ...
Breaking Medicine News(10 mins):
(Date:11/16/2018)... Ala. (PRWEB) , ... November ... ... , the healthcare industry’s leading consumer experience solution provider, congratulates leading provider ... out from a competitive field of 1,000 entries across 17 categories for ...
(Date:11/16/2018)... ... November 16, 2018 , ... Mytonomy, a leader in virtual ... that assessed the usability of and satisfaction with Mytonomy’s video-based microlearning platform among ... presented at the 18th Annual Diabetes Technology Society Meeting, showed that patients were ...
(Date:11/16/2018)... ... November 16, 2018 , ... Design.ME haircare and styling ... quickly refreshes and restores hair between washes. , Designed to lift and ... products, including an instant drying foam that can be used on all hair ...
Breaking Medicine Technology: