Back to Home PageWelcome Guest! Register | Login | Home | Contact Us | Site Map | Advertise | FAQ | Search
Canadian Desi

   Home   Put Your Event   Search
You Are Here: Event > Current Regulatory and Compliance Trends in the Area of Consent Decree

Current Regulatory and Compliance Trends in the Area of Consent Decree

01.00 PM 
10777 Westheimer Suite 1100, Houston, Texas, USA,
Houston Texas 77042

Report Abuse


Topic Background:

Many Years Ago Schering Plough underwent the first Consent Decree.
Since, then many years elapsed and the term Consent Decree was foreign to many employees and employers and to Industry overall.
Over the last Seven Years there has been a Huge Onset of Regulatory Enforcement and Consent Decree Action!!!

Description :

This webinar will focus on current Food and Drug Administration (FDA) Regulatory Guidance ad well as current Regulatory Trends in regards to specifically Consent Decree.
In the recent past there has been an explosion of Regulatory enforcement specifically involving Consent Decree.
This webinar will focus on key Quality Systems that are being highlighted in many of the Consent Decree?s, such as Computer Systems Validation (focusing on 21CFR Part 11, Electronic Records and Signatures (ERES), Equipment Qualification, Change Control Systems, Proper Laboratory Investigations, Corrective Action/Preventative Actions (CAPA), Root Cause Analysis (RCA), etc.
Overall, this Webinar/Course will provide the attendees with the Ultimate set of Tools in order to help their firms during a Regulatory Inspection as well as helping to avoid falling under Consent Decree Status.

Why you should attend the training:

This webinar is directed towards executive management. Quality Assurance, Quality Control and Regulatory and Compliance staff who are involved in Consent Decree projects.

Objectives of the Topic :

Learning about the History of Consent Decree
Discussing the Schering Plough historical Consent Decree Case
Key Quality System Examples Highlighted in Many Consent Decrees
Computer Systems Validation Focus
A) 21CFR Part 1
B) ERES (Electronic Records and Electronic Signatures)
Current Domestic Food and Drug Administration Regulatory Trends
Overall, Current Global Regulatory Enforcement Activity
Summary of Lessons Learned during Regulatory Enforcement/Consent Decree

Areas covered during the Session:

Consent Decree Definitions
Current Food and Drug Administration Trends
Current Regulatory Enforcement Activity
History of Consent Decree
Recent Trends In Consent Decree
Consent Decree Focus on specific Quality Systems
Regulatory Trends Focusing on Computer Systems Validation
21CFR Part 11
ERES (Electronic Records and Electronic Signatures
Current Domestic and International Regulatory Trends

The following Disciplines will benefit directly from this Webinar :

Quality Assurance
Quality Control
Regulatory Compliance
Information Technology (IT)
Laboratory Information Management Systems (LIMS)
Research and Development(R&D)

Webinar includes:

Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of attendance
Note:?Use?coupon?code????and?get?15% off?on?registration.
Phone: 8777824696
Email: subscribe (at)
Report Abuse
Want to manage/update/remove your Listings?
Please enter your email or user-id
List your Event

Similar Events

Houston: Due Diligence ? Quality and Compliance Aspects for Medical Device
DESCRIPTION Mergers and acquisitions are an on-going and important part of the medical device industry. And Due Diligence is a critical part of that process, setting the stage for either success or disaster. Poor due diligence can lead to qual
Date Posted: 18-Apr-16

Houston: Preparing for Regulatory Audits by Carlson E. Patterson
DESCRIPTION This seminar will provide an overview of water systems used for pharmaceutical manufacturing. We will cover validation, monitoring, and analyzing data results. What data collected means, how excursions should be handled, and what acti
Date Posted: 15-Apr-16

Houston: Understanding the Regulatory Requirements for the Over the Counter
DESCRIPTION The US FDA?s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs. To introduce OTC (nonprescription) drug products into the U.
Date Posted: 15-Apr-16

Houston: Implementing a Change Control Quality System Successfully
DESCRIPTION This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking s
Date Posted: 15-Apr-16

Houston: Effective Regulatory Inspections
DESCRIPTION The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able
Date Posted: 18-Apr-16

Houston: FDA vs Health Canada: Similarities and Differences by FDA Expert
DESCRIPTION Successful interaction with regulatory agencies can mean the difference between product license approvals and rejections; the difference between successful and unsuccessful PAI and routine inspections. Not all regulatory bodies are cr
Date Posted: 15-Apr-16

Houston: Proper CAPA Management by Danielle DeLucy
DESCRIPTION In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal
Date Posted: 18-Apr-16

Houston: US EU and Japan GMP Requirements: Practical ICH Area Differences
DESCRIPTION This 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries. Why Sho
Date Posted: 18-Apr-16

Houston: FDA?s New Endotoxin Test Guidance for Human Parenteral Drugs, Biologic
DESCRIPTION Topic Background: FDA current thinking regarding Endotoxin testing has changed. Industry needs to adopt this new thinking in order to prevent observations, which lead to further scrutiny by the agency. Description: The curren
Date Posted: 15-Apr-16

Houston: Auditing the Risk Management File - By Dan O Leary
DESCRIPTION Medical device manufacturers must implement risk management systems for their devices. This can be a complicated system requiring a lot of work and multiple resources. If it is not correct, the regulatory authorities may require correc
Date Posted: 02-Feb-16

Houston: CAPA for Medical Device Companies
DESCRIPTION This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You?ll learn how to streamline and monitor your process to ensure compliance and improved performan
Date Posted: 18-Feb-16

Houston: Internal Audit is a Secret to Medical Device Compliance
DESCRIPTION Internal Audit is an incredibly powerful tool to identify areas of non-compliance. A well designed audit program is a critical tool in understanding, communicating, and mitigating compliance risk. This webinar will help companies use
Date Posted: 18-Feb-16

Houston: FDA Inspection Preparation and Management: Important Considerations
DESCRIPTION This webinar is intended to provide practical and actionable information and guidance on how to proactively prepare for a sustainable FDA inspection and to better manage FDA inspection processes including key points of consideration.
Date Posted: 18-Feb-16

Houston: Introduction to Risk Management: Medical Devices
DESCRIPTION This webinar will cover Risk Management per ISO 14971 throughout the product lifecycle. Risk Management is an important process to methodically and effectively identifying and mitigating risks in the product design and manufacturing p
Date Posted: 18-Apr-16

Houston: Ensuring Compliance of Your Bioanalytical Method Validation with the 2
DESCRIPTION The 2011 EMA Guideline on bioanalytical method validation represents the EMA's current thinking on this topic and was adopted by the CHMP (Committee for Medicinal Products for Human Use) in July 2011. Since then, almost all regulated
Date Posted: 15-Apr-16

Map locations are shown as per geocoding services and they depeneds on the accuracy of the address. If address is wrong it may show wrong map. If you put a listing which shows wrong map, please remove the listing and create a new one with correct address details.

Please note: The information on this site is submitted by users. CanadianDesi never checks accuracy of the information. Please use this information at your risk. If you have any question or concern regarding this listing, or you know that the above information is not accurate, please Contact Us. Thanks.
Please note: The information on this site is submitted by users. CanadianDesi never checks accuracy of the information. Please use this information at your risk. If you have any question or concern regarding this listing, or you know that the above information is not accurate, please Contact Us. Thanks. 

Please Contribute!
Write an Article
Send Community News
Create Photo and Video Albums
Submit Good Pictures
List Useful Websites
Post Jobs
Submit Events
List for FREE!
Social Organizations
Religious Places
Employment Agencies
Email Page
Your Email
Friend\'s Email

Advertise Contact Us Privacy Policy and Terms of Usage FAQ
Canadian Desi
© 2001 Marg eSolutions

Site designed, developed and maintained by Marg eSolutions Inc.