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Out-of-Specifications (OOS)/Out-of-Trend (OOT) Investigations for Analytical Testing

October 1 - October 2

One and a half days interactive presentation, case studies, exercises and workshop.

Deficiencies of Out-of-Spec (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 investigations.  Lack of consistency around investigations and root-cause analysis processes will lead to error and expensive laboratory activities.  This session will discuss the Guidance for Industry on OOS investigation issued in October 2006 by the FDA.  As testing becomes critical to determine the cause of OOS results, investigation process will be discussed and procedure that will minimize OOS.  It will also discuss the documentation system as well as CAPA activities.

Monday October 1, 2018 | Time: 9AM-5PM

Determine failing analytical results

    • Determine regulatory impact of OOS
    • Review of warning letters relating to OOS/OOT
    • Definition of OOS
    • Outline a general OOS procedure

Investigation Process for OOS/OOT

    • Identifying and assessing OOS test results
    • Distinguish out-of-spec and out-of-trend investigations
    • Phase I:  Laboratory Investigation
    • Phase II:  Full Scale OOS Investigation

Discussing case studies for OOS investigation

    • Determine course of actions to process
    • Understand cross-functional investigation
    • Discuss investigation process and critical actions
    • How to prevent OOS investigations.

Tuesday October 2, 2018 | Time: 9AM-1PM

Workshop on:

Develop an investigation plan for different types of data

    • Design a systematic investigation plan
    • Investigate based on different types of analytical data
    • Determine root causes and acceptance criteria
    • Understand different components of an investigation report

Establish trends and Corrective Actions and Preventive Actions (CAPA)

    • Determine Critical Quality Attributes (CQA) to monitor quality
    • Establish trends using control charts
    • Determine quality markers for release and stability
    • How to minimize OOS/OOT investigation

Interactive discussions on trending and OOT investigation


Kim Huynh-Ba, Executive Director, Pharmalytik

Kim Huynh-Ba has 28 years of experience in quality management system, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik (www.pharmalytik.com). Since 2003, she has provided consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching quality audit, Good Manufacturing Practices, ICH regulations, and pharmaceutical analysis.

Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. Kim is a member of the USP Council of Expert chairing the Chemical Medicines IV Expert Committee (2015-2020). She is also the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-present). She is also a member of the PQRI Stability Shelf-life working group.

Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets (2010).

This course will benefit analytical chemists, staff scientists, investigators in quality control lab, R&D, production, manufacturing, contract labs, quality assurance, regulatory affairs, laboratory auditors, lab inspectors, data reviewers, lab investigators.

This course is not intended for microbiologists.

Registration Fee & Discounts

Early Bird: Till Sept. 16, 2018

Regular Price: Sept. 17, 2018 to Oct. 01, 2018

$688 CAD + HST $788 CAD + HST

Academia / Government

At all time (Save Over $200.00)

$498 CAD + HST

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.

Group Registration Discount
Group Registration is available for all our live events. Please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Cancellation Policy
Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.

Course Venue & Hotel Accommodation

Sheraton Montreal Airport Hotel

555 Boulevard McMillan
Montreal, Quebec
H9P 1B7 Canada
Tel: 514 631 2411
Website: http://www.sheratonmontrealairport.com/

Guests are responsible for their own accommodations. IPA has arranged a special room rate of $149 + taxes for attendees at the Sheraton Montreal Airport (Course Venue). To reserve a room at the Sheraton with our group rate, please call the hotel: 514 631 2411 and mentioned group code: IPA




October 1
October 2
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Montreal, Canada


(416) 410 7402