Sandy Hatten: The History of Quality or How “Quality” has Changed
Sandy Hatten has worked in the pharmaceutical industry for 35 years, primarily in Quality and Regulatory leadership roles. She is currently the Senior Vice President of Quality and Regulatory Affairs with Flamel Technologies, a specialty pharmaceutical company with offices in the US and Europe. In her role with Flamel, she has responsibility for all Flamel Quality and Regulatory Affairs functions in France, Ireland and the US. Prior to joining Flamel, Sandy served as Senior Vice President of Quality with Mallinckrodt Pharmaceuticals. In that role, she was responsible for all Global Quality functions, which included 12 manufacturing plants (US, Canada, The Netherlands, and Ireland) in addition to all corporate Quality functions. Prior to joining Mallinckrodt, Sandy held Quality leadership positions with KV Pharmaceuticals, Cardinal Health, Perrigo, Bausch&Lomb, and Watson Pharmaceuticals (now Actavis).
During her 35 years in the pharmaceutical industry, she has had the opportunity to work with brand as well as generic companies. She also worked as a consultant for several years and in that role provided Quality and Regulatory advice and support to a variety of companies, both large and small. Her background includes, in addition to QA/QC and Regulatory, experience in Clinical Operations, R&D, Commercial Operations and Supply Chain.
Steven Lembark: Using Non-Parametric Statistical Analysis
Real data is often messy. Non-parametric statistical analysis offers a variety of ways to analyze the data that really happens. This talk provides a brief introduction to non-parametrics with examples from safety and QA analysis.
What is Non-parametric statistical analysis?
It’s statistics that is not based on parameterized probability distributions, instead parameters are determined by the training data, not the model. Nonparametric statistics make no assumptions about the probability distributions of the variables being assessed. The difference between parametric models and non-parametric models is that the former has a fixed number of parameters, while the latter grows the number of parameters with the amount of training data.
He has ver 30 years experience installing, managing, supporting, and programming systems from CAD/CAM to data warehouses on platforms from VMS to Solaris and Linux. He has worked on startup and refactoring projects in aerospace, telecom, financial, health-care, bioinformatics, web services, and manufacturing.
ASQ St. Louis Section Monthly Dinner Meeting
Tuesday, Feb 16, 2016
05:30 PM – 09:00 PM Central
5201 Southwest Avenue
St Louis, MO 63139
Tuesday, January 19, 2016
There are many tools that are used to manage projects, and many time, we focus on executing the tools and forget about the people side of the equation. This is a recipe for disaster as the people side of any project is as important, if not more important, than the tools we use. If the people side is not managed properly, the project will fail.
This presentation will discuss the people side of a project by exploring team dynamics. We will discuss team members, team structure, common pitfalls and how to get your team to a high level of performance. This is an important part of the ASQ Body of Knowledge. As such it is included in the BOK for numerous ASQ certifications.
Tuesday, Jan 19, 2016
“So you want to be a consultant and provide performance excellence…or perhaps lead your organization to performance excellence”
The presentation will include brief review of the pros and cons of business improvement consulting, as well as a discussion of why one should or should not consider becoming a consultant.
The criteria for leading an organization to performance excellence is similar whether one is an outside the organization consultant or an internal champion. These attributes and challenges will also be discussed. This is planned to be a semi-open discussion between the presenter and the audience.
Tuesday, Dec 8, 2015
A Night of Comedy, ASQ Awards, and Collaborative Design Process
Our headliner and MC is fresh from:
- COMEDY CENTRAL
- America’s Funniest People
- Last Comic Standing
But that’s not all… An interactive, participatory, and FUN workshop on “ENGINEERING PROCESS DESIGN” will use the OTHER side of your brain…
And if that isn’t enough, there will be an opportunity to start your holidays early, with a GIVING TREE to benefit Epworth Children and Family Services.
Bring a gift, or just bring a donation and we’ll do the shopping for you!
- Bring a gift for the Children of Epworth
- A team-building icebreaker project on Engineering Process Design
- The annual presentation of ASQ awards
Saturday, NOV 7, 2015 from 08:00 AM – 12:00 PM Central
Change management: why it’s critical to accelerate deployment of initiatives
Attend this workshop and learn about the change process, Change Management Steps, why it’s critical to accelerate deployment of initiatives, and several change management tools Get hands-on experience using the tools to be ready to deploy it at your business.
Learn how to become a change leader, needed personality / characteristics, and how these tools complement Lean, Six Sigma, and Project Management tools and concepts.
Tuesday, Oct 20, 2015
What are the new Document Requirements?
You will learn about the requirement for a quality manual — there is none! How about quality procedures — None! quality records — Only to the extent necessary… Hard requirements for documentation are replaced with the term “documented information”.
The new standard is focused less on documentation and more on performance, risk, and designing in quality.
Risk is the new focus to designing in quality.Read More»
Tuesday, Oct 20, 2015
The process of developing a Hoshin strategic plan summary, sharing it with employees, and regularly reviewing the metrics that are clearly aligned with the organization’s core objectives and strategy may be infinitely more effective than annually asking employees to memorize the quality policy in preparation for the upcoming registrar audit.
This presentation will provide an overview on developing a Hoshin strategic plan summary as well as Hoshin action plans, implementation plans, and implementation reviews and how these steps correlate to ISO 9001:2015 requirements.
Saturday, SEP 26, 2015 from 08:00 AM – 12:00 PM Central
What does ISO 9001:2015 require for risk analysis and risk management?
Learn what Risk Based Thinking is and how to apply it to your QMS.
While a formal process of risk analysis or risk management is not required in the ISO 9001:2015 standard, the concept of risk is included in eight areas of the current draft of the new standard.
1. Determining risks and opportunities that affect the quality management system.
2. Planning changes to the quality management system.
3. Evaluating processes, as part of the process approach.
4. Establishing appropriate controls of external providers (such as suppliers)
5. Identifying risks that can affect the company’s products, services, and overall customer satisfaction.
6. New product design and development risks.
7. Determining post-delivery support risks (e.g. warranty, maintenance, and other services).
8. Establishing monitoring and measurement of risks.
The inclusion of risk throughout the standard is referred to as “risk based thinking”. The standard does not require specific processes or procedures for risk analysis, like Failure Modes and Effects Analysis (FMEA), but using FMEAs and Control Plans will provide a basis for risk analysis and management. In this fast paced class we will review some of the core tools used to identify, quantify, and control risks including: Process diagram, FMEA, and Control Plan.Read More»
Tuesday, Sept 15, 2015
Defect Mapping is a problem solving tool used to visually identify and track physical locations and types of defects on a product. As a defect occurs during a process on a product, the location of the defect is identified on a map.
The Defect Map provides information on the physical location of the defect on the product and additional pertinent information as well. The more visual you can capture issues, the easier it is to move forward to defining root cause and corrective action.
An introduction to the basics of reliability engineering that clarifies the definition of reliability and shows how it differs from many other quality functions. Key concepts, primary tools, and the impact of reliability are highlighted.
Examples from several products and industries are used to illustrate the role of reliability engineering. The presentation concludes with a description of the ASQ Reliability Division and the services it provides.Read More»