Skip to main content

How to properly investigate OOS/OOT Results

Overview
This webinar will review the regulatory requirements for investigating an OOS Investigation.
The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Why should you attend this webinar?
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations
Areas Covered in the Session:
  • FDA requirements for handling OOS/ OOT results
  • Phase I- Laboratory Phase of Investigations
  • Phase II a Full Scale Investigation
  • Concluding an Investigation
  • Out-of Trend investigations
  • Common pitfalls during OOS Investigations
  • Review of recent OOS related citations in Warning Letters
Who can Benefit:
  • Quality Assurance/Quality Control Directors, Managers, and Specialists
  • Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
  • Engineering/Development Directors, Managers, and Specialists
Visit:https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1242&speakerid=59

Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

Essentials of Affirmative Action and OFCCP Compliance

Compliance Key INC  -  Human Resource Training Online                                                                  Janette Levey Frisch Janette Levey Frisch is Keynote Speaker at Compliance key Inc. She is founder of  The EmpLAWyerologist Firm, has over 20 years of legal experience, more than 10 of which she has spent in Employment Law. It was during her tenure as sole in-house counsel for a mid-size staffing company headquartered in Central New Jersey, with operations all over the continental US, that she truly developed her passion for Employment Law.   Webinar Id:   CICJE001  10.00 AM PT | 01.00 PM ET   01/09/2018  Duration: 90 mins  Overview If you are a federal contractor, having a firm grasp on the essentials ...
Post a Comment
Read more

Risk and Controls Matrix for SOX, Assurance and Internal Audit

Compliance Key INC  -  SOX Training Online Overview This webinar is created to equip young risk and compliance professionals with the skills necessary to prepare a Risk and Controls Matrix, including the following: Discover the objectives, components and requirements of effective internal controls Leveraging internal control frameworks to create a risk and controls matrix Developing risk identification and management strategies to implement now Learning how to design internal controls Learning how to evaluate the design and operating effectiveness of internal controls Why should you attend this webinar? Whether you are planning a SOX engagement, or an internal audit, regulatory compliance requirements, or other separate evaluations, just where do you start with planning for the engagement? How do you complete the necessary risk and control documentation that you will need to successfully complete the engagement? Attend this webinar to learn more. Areas...
Post a Comment
Read more

Understanding Design Controls

Compliance Key INC  -  Medical Device Training Overview Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation, however, the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed. Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore. Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step. The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Qua...
1 comment
Read more