Navigation Links
FDAnews Announces: Early Bird Pricing Ends July 28 for Clinical Quality Assurance: Roles and Responsibilities for Auditors and Managers, Aug. 22-23, 2017, Arlington, VA
Date:7/24/2017

Clinical Quality Assurance:
Roles and Responsibilities for Auditors and Managers
**Presented by FDAnews and MSceppa Consulting **
Aug. 22-23, 2017 – Arlington, VA
http://www.fdanews.com/cqa

Early bird pricing for Clinical Quality Assurance ends on Friday, July 28.

Increased FDA scrutiny and growing demands to track and report adverse events place even greater pressure on aclinical quality assurance program. Get ready for tougher questions from FDA investigators and ensure that clinical trials meet the highest quality standards.

In two action-packed days, attendees will learn what FDA investigators use to evaluate sites.

This interactive workshop will teach attendees how to develop risk-based CQA processes and compliance readiness.

Attendees will benefit from the first-hand knowledge and experience of workshop leader and expert Michelle Sceppa, a 25-year quality assurance and regulatory compliance veteran in both the pharmaceutical and medical device industries.

She’ll walk attendees step by step through such details as:

  •     A review of how FDA conducts clinical inspections and the top 5 GCP violations
  •     How to write GCP audit SOPs — what elements to include
  •     Writing a central laboratory audit SOP and why this SOP is needed
  •     Selecting sites to be audited — creating a master audit plan and how to make sure it is met
  •     Audits of a central laboratory — why lab data and testing are a critical component of the clinical study

Throughout the workshop, attendees will also participate in invaluable Interactive Exercises that will make them feel like they're engaged in an actual inspection, giving them priceless hands-on experience that will serve them well for years to come.

Finally, attendees will walk away after two days with valuable tools they'll be able to put to use immediately:

  •     Slides from PowerPoint presentations
  •     Case review worksheets
  •     Interactive exercise worksheets
  •     SOPs, forms, templates for CQA audits: site, CRO and central laboratory
  •     Copies of applicable FDA/ICH regulations and guidances

Don't miss out on this unique opportunity to learn to confidently conduct comprehensive and effective CQA audits. Early bird pricing ends on Friday, July 28.

Meet the Presenter:
Michelle Sceppa, principal and founder of MSceppa Consulting has more than 25 years of experience in quality assurance and regulatory compliance in the pharmaceutical and medical device industries. As a lead auditor, she has conducted and managed more than 300 internal and external audits for drug, biologic and medical device firms in the US and Europe.

Who Will Benefit:

  •     Clinical quality assurance managers and auditors
  •     Clinical site directors
  •     Clinical research associates/coordinators
  •     Regulatory affairs
  •     IRB administrators

Conference Details:
Clinical Quality Assurance:
Roles and Responsibilities for Auditors and Managers
**Presented by FDAnews and MSceppa Consulting **
Aug. 22-23, 2017 – Arlington, VA
http://www.fdanews.com/cqa

Tuition:
Early Bird (until July 28): $1,597
Regular Price: $1,797
Significant team discounts are available.

Easy Ways to Register:
Online: http://www.fdanews.com/cqa
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/cqaearlybirdaug2017/prweb14519493.htm.


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


Related medicine news :

1. FDAnews Announces — "FDA’s Work Plan ... the 21st Century Cures Act ... and You: Disruptive? Absolutely. But ... How Much?" Webinar, Aug. 14, 2017
2. FDAnews Announces — Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line Webinar, Aug. 9, 2017
3. FDAnews Announces — ClinicalTrials.gov and the New Final Rule (42 CFR Part 11): What Strategic Decisions Do You Need to Consider? Webinar, Aug. 2, 2017
4. FDAnews Announces — Spreadsheet Validation 2017: Tools and Techniques to Meet FDA Requirements Webinar, July 18, 2017
5. FDAnews Announces — New Brief — Device Accessories: Understanding and Implementing FDA’s Guidance
6. FDAnews Announces — New Management Report — Drug or Device? How the 21st Century Cures Act Impacts Combination Products
7. FDAnews Announces — New Book — Guide to FDA and EU Medical Device Regulations: 2017 Edition
8. FDAnews Announces — Disinfectant Testing and Validation Webinar, June 29, 2017
9. FDAnews Database — Limited Time Offer Save $500 on 483sOnline.com
10. FDAnews Announces — Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny Webinar, June 27, 2017
11. FDAnews Announces — Medical Device Premarket Regulatory Pathways: Maximizing Efficiency—Saving Time, Money & Resources Webinar, June 7, 2017
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/18/2019)... , ... July 18, 2019 , ... Gateway Genomics ... children, announces a new publication titled, “ Accurate Fetal Sex Determination from Maternal Blood ... In the study, DNA blood samples were collected from 108 women at an average ...
(Date:7/17/2019)... ... July 17, 2019 , ... The ... online Family Nurse Practitioner program. The honor is given to distance learning courses ... , The Catalyst Awards honor institutions from around the world that produce exemplary ...
(Date:7/17/2019)... SAINT PAUL, Minn. (PRWEB) , ... July 17, ... ... created to assist healthcare providers working with the ICD-10 coding set, is launching ... listeners Continuing Education Units (CEUs) at no additional charge, officials announced this week. ...
(Date:7/17/2019)... YORK (PRWEB) , ... July 17, 2019 , ... A ... the Journal of the American Medical Association (JAMA), shows for the first ... sepsis deaths in the state. Sepsis is the body’s extreme response to infection. It ...
(Date:7/17/2019)... ... , ... Dr. Jonathan Zaidan, MD, FACOG, President of Women’s Excellence discusses a ... The show airs on Wednesday, July 17ths at 7pm. The show podcast will ... Ann Thomas discuss the challenges that women face when it comes to weight loss ...
Breaking Medicine News(10 mins):
(Date:7/19/2019)... ... July 19, 2019 , ... Cloudticity, ... of Chris Whaley as Senior Vice President of Business Development. , Whaley ... experience better using cloud technology. , As a technology leader with more than ...
(Date:7/19/2019)... ... July 19, 2019 , ... Robinson Pharma, Inc., is proud to ... facilities was audited by the Safe Quality Food (SQF) Institute using an accredited certification ... Safety Code for Manufacturing, Edition 8. , The SQF Certification program is trusted by ...
(Date:7/18/2019)... ... July 18, 2019 , ... ComplianceLine, the ... 20 years, announced today it is moving into new corporate headquarters in Charlotte ... are thrilled to be moving into the new office which will allow our ...
Breaking Medicine Technology: