Labcompliance Video Seminar
Video clips are recorded and imbedded in PowerPoint presentation
slides. This allows highest flexibility. For example slides and
clips can be skipped or replayed several times. The PowerPoint
presentation with video clips come on a CD or as web download.
Reference material such as 10+ best practice documents can be
downloaded from a password protected website. The site and its
updates can be accessed for two years.
Video Seminar 103
Managing OOS Test Results and Failure
Implementing the final FDA Guidance for
Pharmaceutical Quality Control Laboratories and Production
With Dr. Ludwig Huber
No or inadequate procedures for handling out of specification (OOS) situations,
failure investigations and corrective and preventive actions (CAPA) are amongst
the most frequently found deviations in FDA warning letters. Companies have
procedures but either they are not adequate or are not followed. Now the FDA has
just released the final guidance on OOS test results. The scope has been
expanded from API and finished product testing to include testing of raw
materials, in-process materials and stability studies. In addition the new
guidance puts more stringent requirements on the Quality Control Unit. The
industry is unsure how to implement the new guidance.
Key Questions related to OOS and failure investigations are:
- What's new about the final FDA OOS guidance?
- What are the critical requirements
- What exactly are the expectations of inspectors?
- Does the new guidance apply to APIs and what are
requirements of ICH Q7A?
- When should a full investigation be initiated?
- Who has overall responsibility for evaluating investigation
- How many times can/should we retest?
- How to conduct a batch failure investigation?
- Can we release a batch even if an OOS test is not
- How to deal with out-of-trend (OOT) results?
- How to develop FDA compliant corrective and preventive
- How can I avoid OOS situations BEFORE they occur?
- What if the result meets compendial specs but not our
How does the video seminar help:
Answers will be presented by Dr. Ludwig Huber in a new
interactive video seminar. During the seminar, the speaker will
present the requirements of the new FDA OOS guidance and give
practical recommendations. After the seminar, an extensive list of
reference material like SOPs, worksheets, templates and examples
will help immediate and cost effective implementation. The SOPs have
been updated according to the new FDA OOS guidance
During the interactive presentation you learn about:
- FDA regulations and guidelines
- FDA's final Guidance for Industry: Investigating
Out-of-Specification (OOS) Test Results for Pharmaceutical
- Learning from recent FDA 483's and warning letters
- Requirements of ICH Q7A for APIs
- Developing SOPs for OOS situations and laboratory failures
- Managing formal and informal investigations in laboratories
- Retesting: when and what and how many times
- Developing corrective and preventive action plans
- Root cause analysis
- Strategies to avoid OOS situations BEFORE they occur
- FDA compliant documentation of OOS, failures investigations,
root causes and CAPA
And for easy and instant implementation:
download 10+ documents from special seminar website
- Handling OOS results (updated according to FDA's final OOS
- Laboratory Failure Investigations
- Corrective and Preventive Actions
- Investigating Manufacturing Incidents
- OOS Results (updated according to FDA's final OOS guidance)
- Reference Articles
- Preventing Out-of-Specification (OOS)
- Situations Caused by Laboratory Errors
- CAPA: A fundamental quality subsystem
- How to avoid warning letters
- Five Warning letters and/or Inspectional observations
related to OOS and CAPA
- FDA Guidance for Industry:
Investigating Out of Specification (OOS) Test Results for
Pharmaceutical Production (October 2006)
- DOE: Root Cause Analysis Guidance (69 pages)
Who should attend?
- Laboratory managers and supervisors
- GLP/GMP auditors
- QA/QCU managers and personnel
- Responsible persons (for EU compliance)
- Analysts and other laboratory staff
- Regulatory affairs
- Human resources (HR) managers and staff
- Training departments
Cost and Ordering
Video seminar - Web download
- Download the video presentation from a password protected website
(approx. 150 Mbytes)
- Order includes all reference material.
- Share the video and all reference material at your site
Video seminar - CD
- Get the CD in your mail
- Order includes all reference material.
About Dr. Ludwig Huber
Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
||Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.
Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,