partners with its clients to develop and implement effective risk management procedures to successfully commercialize and sustain safe and effective products.
Q9 Consulting, Inc. was founded in 2007 by Mike Wakshull. The name originates from ICH Q9, Quality Risk Management for the pharmaceutical industry. Mike managed Corporate Quality Risk Management for Amgen, the world's largest biotechnology company. Mike's experience with medical device product risk management has focused on implementation of ISO 14971.
Mike was a technical editor and primary contributor to the 2nd edition of the risk management chapter 11 of the Guide to the Project Management Body of Knowledge (PMBoK Guide). This is an ANSI and ISO standard for project management. He has contributed to the risk management chapter of the 4th edition of the PMBoK Guide.
Services offered include:
- Expert witness testimony
- Project Management Consulting
- Risk Management Consulting
- Project Management Training
- Risk Management Training
- Forensic Document Examination
In 1999 Mike wrote the first 4-day Project Risk Management course for Learning Tree International. In 2002 he presented 2 4-day risk management classes for PMI Seminars World. Mike teaches project risk management for the University of California at Irvine's Extension University. He wrote and presented globally the internal Product Quality Risk Management training classes at Abbott Vascular.
Q9 Consulting, Inc. serves Southern California counties of Riverside, San Diego, Orange, San Bernardino, and surrounding regions.
Work is accepted from all other locations.
Areas of Expertise
View Mike Wakshul's Expert Witness Profile
- Managing large information systems projects
- Project risk management
- Pharmaceutical product uality risk management
- ICH Q9
- Medical Device product quality risk management
- ISO 14971
- Training classes
- Public speaking
As with any other profession, document examiners have a range of expertise and experience. As important as it is for your client to make a clear assessment of your abilities, it is up to you to determine in advance, with a high degree of accuracy, whether the document examiner you plan to hire will perform the most accurate assessments and be ready to back up those assessments with a scientifically repeatable methodology in court.
None of us wants to feel that our opinions are tainted by bias. The ability to recognize when bias is an influence in an expert's opinion and the skill of an expert to overcome his or her biases is integral to an expert's credibility.
The Most Dangerous Animal of All was co-written by the estranged son of California’s infamous Zodiac killer to reveal his father’s true identity. When the book hit the streets the skeptics were in full force. Just like those who mocked the boy who cried wolf, no one could blame them. Too many people had already claimed to either be the killer or to know who he really was.
Forensic document examination, performed correctly, is a reliable discipline that can demonstrate the innocence of your client or the guilt of your opponent. Used strategically, it can help you settle out of court. When court is necessary, your document examiner can present a case so clearly that the outcome is beyond doubt. To achieve this, your document examiner must be proficient in the latest techniques and adept at reporting results.
" Q9 Consulting, Inc. announces the release of a new book, The End of the Zodiac Mystery, How Forensic Science Helped Solve One of the Most the Most Infamous Serial Killer Cases of the Century by Michael Wakshull."