Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations

A Comprehensive Live Training Program on Best Practices & FDA Regulatory Requirements

 

Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations, Key Components and a Comprehensive Review of the FDA Requirements

Avoiding Deficiencies and Ensuring Continuous Improvement through a Complete Investigation Process

Annual 4-Part Live Training Program
Instructor: Kim Huynh-Ba Biography>>>

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Deficiencies of OOS investigations continue to be the major cause of warning letters in the pharmaceutical industry. FDA requires that all out-of-specification results must be investigated; therefore, an effective and compliant quality management system requires well-documented, thorough investigations for OOS. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS and OOT. Lack of consistency around investigation and root-cause analysis processes will lead to error and expensive laboratory activities. This series will give a complete discussion on OOS/OOT investigation practices.

The first session will discuss the FDA Guidance for Industry on OOS/OOT investigation in details. Once an OOS value is discovered, one needs to confirm if it is caused by the measurement or the manufacture. Root cause analysis must be performed as well as determine necessary corrective action and preventive action. As testing become critical to determine the cause of OOS results, investigation process will be discussed.

In the second session, discussion will include OOT for stable and changed properties of drug products to establish trend to monitor product profile. Risk assessments will be introduced to determine critical quality attributes and how to work with cross-functional team to continuously improve the product.

The third session will cover the documentation for OOS investigation, which is one of the main causes of Warning Letters. Discussion will include of how an investigation plan is designed, acceptance criteria are set and timelines and responsibilities are determined. This session will also introduced the content of an investigation report.

This series will conclude with a session that discusses the deficiencies in this area. It will bring the discussion on CAPA and how ruggedness must be built into the analytical procedure to prevent OOS occurrences. It will also cover the performance metrics as well as discuss the key performance indicators through metrics, so system performance can be determined.

Overall, the series will give the analyst a complete view of the investigation process and how to monitor OOS and OOS to continuously improve product performance. This series will include 4 individual instrcutor-led live training webinars on investigation process structured as following:

Session 1: Identification of Out-of-Specification (OOS) and the Investigation Process - A Comprehensive Review of the FDA Guidance and Requirements
Date: Wednesday October 17, 2018

Learning Benefits:

• Identifying and assessing OOS test results
• Phase I: Laboratory Investigation
• Phase II: Full Scale OOS Investigation
• Identify root causes
• CAPA and follow up


Session 2: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Date: Wednesday October 31, 2018

Learning Benefits:

• Recognize different types of OOT results
• Establish trend for release and stability data
• Understand risk assessments to determine Critical Quality Attribute (CQA)
• Determine course of actions to process
• Understand cross-functional investigation
• Monitoring product trends to avoid OOS


Session 3: Developing Investigation Plans and Writing Investigation Reports
Date: Wednesday November 28, 2018

Learning Benefits:

• Design a systematic investigation plan
• Determine root causes
• Establish acceptance criteria for investigation
• Components of an investigation report
• Timelines and responsibilities
• Establish Corrective Actions and Preventive Actions


Session 4: Laboratory Deficiencies and How to Minimize OOS/OOT
Wednesday December 5, 2018

Learning Benefits:

• Review regulatory deficiencies to establish investigation process
• Build ruggedness into the analytical procedures to prevent OOS occurrences
• Build compliance into the investigation process to minimize OOS
• Determine Key Performance Indicators (KPI) to monitor process
• Establish documentation and performance metrics

Part 1: Identification of Out-of-Specification (OOS) and the Investigation Process - A Comprehensive Review of the FDA Guidance and Requirements

Live, Interactive Training Webinar

Date: Wednesday October 17, 2018
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

The first session will discuss the FDA Guidance for Industry on OOS/OOT investigation in details. Once an OOS value is discovered, one needs to confirm if it is caused by the measurement or the manufacture. Root cause analysis must be performed as well as determine necessary corrective action and preventive action. As testing become critical to determine the cause of OOS results, investigation process will be discussed.

Learning Benefits:
-Identifying and assessing OOS test results.
-Phase I: Laboratory Investigation.
-Phase II: Full Scale OOS Investigation.
-Identify root causes.
-CAPA and follow up

Webinar outline and time breakdown:

Date: Wednesday October 17, 2018

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM GMP requirements for investigations,
Identifying and assessing OOS test results,
Phase I: Laboratory Investigation
10:30 AM Break
10:40 AM Phase II: Full Scale OOS Investigation,
Identify root causes,
CAPA and follow up,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 2: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management

Live, Interactive Training Webinar

Date: Wednesday October 31, 2018
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

In the second session, discussion will include OOT for stable and changed properties of drug products to establish trend to monitor product profile. Risk assessments will be introduced to determine critical quality attributes and how to work with cross-functional team to continuously improve the product.

Learning Benefits:
-Recognize different types of OOT results.
-Establish trend for release and stability data.
-Understand risk assessments to determine Critical Quality Attribute (CQA).
-Determine course of actions to process.
-Understand cross-functional investigation.
-Monitoring product trends to avoid OOS.

Webinar outline and time breakdown:

Date: Wednesday October 31, 2018

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Recognize different types of OOT results,
Establish trend for release and stability data,
Understand risk assessments to determine Critical Quality Attribute (CQA),
10:30 AM Break
10:40 AM Determine course of actions to process,
Understand cross-functional investigation,
Monitoring product trends to avoid OOS,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 3: Developing Investigation Plans and Writing Investigation Reports

Live, Interactive Training Webinar

Date: Wednesday November 28, 2018
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

The third session will cover the documentation for OOS investigation, which is one of the main causes of Warning Letters. Discussion will include of how an investigation plan is designed, acceptance criteria are set and timelines and responsibilities are determined. This session will also introduced the content of an investigation report.

Learning Benefits:
-Design a systematic investigation plan.
-Determine root causes.
-Components of an investigation report.
-Timelines and responsibilities.
-Establish Corrective Actions and Preventive Actions.

Webinar outline and time breakdown:

Date: Wednesday November 28, 2018

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Design a systematic investigation plan,
Determine root causes,
Establish acceptance criteria for investigation,
10:30 AM Break
10:40 AM Components of an investigation report,
Timelines and responsibilities,
Establish Corrective Actions and Preventive Actions,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 4: Laboratory Deficiencies and How to Minimize OOS/OOT

Live, Interactive Training Webinar

Date: Wednesday December 5, 2018
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

The series will conclude with a session that discusses the deficiencies in this area. It will bring the discussion on CAPA and how ruggedness must be built into the analytical procedure to prevent OOS occurrences. It will also cover the performance metrics as well as discuss the key performance indicators through metrics, so system performance can be determined.

Learning Benefits:
-Review regulatory deficiencies to establish investigation process.
-Build ruggedness into the analytical procedures to prevent OOS occurrences.
-Build compliance into the investigation process to minimize OOS.
-Determine Key Performance Indicators (KPI) to monitor process.
-Establish documentation and performance metrics.

Webinar outline and time breakdown:

Date: Wednesday December 5, 2018

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Review GMP requirements and regulatory expectations,
Review regulatory deficiencies to establish investigation process,
Build ruggedness into the analytical procedures to prevent OOS occurrences,
Build compliance into the investigation process to minimize OOS,
10:30 AM Break
10:40 AM Determine Key Performance Indicators (KPI) to monitor process,
Establish documentation and performance metrics,
Maintain compliance throughout product lifecycle,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


This comprehensive 4-Part live training program includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditors

Click Here to Register for this Live Training Program

Instructor: Kim Huynh-Ba

Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.

She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… Full Bio>>>


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• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.


Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland

Clients: