Best Practices for Investigating Deviations

OVERVIEW
Deviation investigations are a very common topic to be reviewedduring FDA investigations.  Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit.  Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.
WHY SHOULD YOU ATTEND
Proper root cause analysis of the issue is necessary to make sure that the firm is focusing on the real problem and subsequently the proper corrective and preventative actions can begin.
This webinar will help attendees understand how to use root cause analysis tools and CAPA plans to successfully resolve deviations and non-conformances.
Deviation Investigations Training Program

AREAS COVERED
  • Review of  FDA and Regulatory Requirements for Investigations
  • What is  the definition of a Deviation?
  • Types of Deviations/Identification of Deviations
  • Conducting the Investigation
  • Interviews – dos and don’ts
  • Source Documents/Evidence
  • Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
LEARNING OBJECTIVES
  • Discuss what to do when problems occur
  • Outline the requirements of the Deviation and procedure including the deviation report
  • Choose the most appropriate Root Cause Analysis methods for the situation
  • Discuss how to conduct the deviation and the tools to be used in the process
  • Review and discuss an example deviation using the tools suggested
WHO WILL BENEFIT
Quality Assurance/Quality Control Directors, Managers, and Specialists 
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists 
Engineering/Development Directors, Managers, and Specialists

For more detail please click on this below link:
https://goo.gl/HUHSBS

Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616

Fax: +1-888-909-1882

Comments

Post a Comment

Popular posts from this blog

BCBS 239 – Principles of Effective Risk Data Aggregation and Risk Reporting

Image
OVERVIEW Understanding the process required to ensure compliance withBCBS 239 as well as tips on ensuring that the right data is utilized. Finally, a detailed step by step analysis of COSO requirements and what a business can do to meet expectations. COSO continues to provide guidance and establish standards for performance in risk related processes.  BCBS 239 is the latest in a series of instructions which focuses on risk data aggregation. This webinar will include discussions on the risk data aggregation capabilities and internal risk-reporting practices (the Principles) that enhance risk management and decision making processes at financial institutions. BCBS 239 Compliance WHY SHOULD YOU ATTEND Early in 2015, the Basel Committee published the second progress report on bank’s adoption of BCBS 239. Several banks, at that time, stated that they would not be able to comply with the new standards by the 2016 deadline date.  However, regulators are now looking a...
Read more

Effectively Handle Toxic People for Better Productivity and Less Drama in 2020

Image
We all have people who push our buttons and if that relationship is with our boss, colleagues or clients, it can drain our energy, take us off track and infect the other areas of our life. Our upcoming webinar discusses successful strategies and tips for building a positive, productive relationship by knowing how to effectively respond to, cope, and manage the impact of their negative and toxic behavior in the workplace. The webinar covers the following key areas: ·          Identify and control the impact of difficult people so that you can keep the situation from escalating further ·          Differentiate the 4 types of attitudes and understand how they develop in order to keep your cool in a variety of situations ·          Utilize various verbal and non-verbal communication techniques and situational strategies that you can use to de-escalate and effe...
Read more

Handling a Chaotic Work Environment: How to Prioritize Work and Make Good Decisions Under Pressure

Image
OVERVIEW This highly interactive webinar offers you and your team an array of practical tools to help you get things done in today's chaotic and constantly changing work environment. You’ll learn practical tips on how to make good decisions under pressure to earn buy-in from bosses, coworkers and customers. In a workshop environment, you will participate in valuable exercises utilizing real-world case studies.  You'll emerge with an action plan you can use right away for managing through chaos and to master expanding workloads and complex decisions. WHY SHOULD YOU ATTEND • Are you feeling overtasked, over-worried and overdone? • Could you use a ‘managing multiple priorities effectively refresher”, to help you get a better handle on things? • Would you like to brush up on your management and delegation skills? If you answered  “yes”  to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through those important topics, ke...
Read more