Warren bill would get feds into generic drug manufacturing – POLITICO

Warren is one of several senators eyeing White House runs who have introduced bills targeting the pharmaceutical industry. Just last week, Sens. Jeff Merkley (D-Ore.), Kamala Harris (D-Calif.) and Amy Klobuchar (D.-Minn.) introduced the CURE High Drug Prices Act, which would allow the federal government to block price increases on certain drugs. Merkley put forward separate legislation, the Low Drug Prices Act, weeks earlier. And Sen. Bernie Sanders (I-Vt.) introduced his own bill, the Prescription Drug Price Relief Act, in November.

The flurry of bills suggests that the powerful pharmaceutical industry will be a major populist target during the Democratic presidential primary and possibly the general election, as millions of Americans struggle with rising health care costs.
— Read on www.politico.com/story/2018/12/17/elizabeth-warren-bill-drug-manufacturing-prices-1067916

An Office of Drug Manufacturing. That could be interesting.

ASQ Lean and Six Sigma Conference – Speaker

I will be presenting at the ASQ Lean and Six Sigma Conference on March 5, 2019 on the topic “Training as Part of Lean Change Management.”

If you plan on being at the conference, let me know. I always enjoy sitting down with colleagues and chatting.

This topic unites three of my passions: change management, knowledge management and continuous improvements. 

One of the key parts of any change stemming from a project is preparing people to actually do the work effectively. Every change needs to train and building valid and reliable training at the right level for the change is critical.

Training is valid when it is tied to the requirements of the job – the objectives; and when it includes evaluations that are linked to the skills and knowledge started in the objectives. Reliability means that the training clearly differentiates between those who can perform the task and those who cannot.

In this session we will take a risk based training approach to the best outcome for training. The following criteria will be examined and a tool provided for decision making:

  • Is a change in knowledge or skills needed to execute the changed process?
  • Is the process or change complex? Are there multiple changes?
  • Criticality of Process and risk of performance error? What is the difficulty in detecting errors?
  • What is the identified audience (e.g., location,size, department, single site vs. multiple sites)?
  • Is the goal to change workers conditioned behavior?

Armed with these criteria, participants will then be exposed to specific training tools to enable quick adoption of the training:reader-doer, pre-job briefings, and structured discussions. Advantages of each method, as well as common mistakes will be evaluated.

Knowledge management as a key enabler to lean improvements will be examined. Participants will gain an understanding of how to draw from their organizations formal and informal knowledge management systems, and gain an understanding a tool to ensure results of a lean project feedback into the knowledge management system.

Participants will leave this training with the ability to execute decision making around providing successful training for their lean projects and ensuring that this deepens their organization’s knowledge and the ability to apply that knowledge in the future.

Validation, Disposition and Change Control

A colleague asks “How do you manage changes and disposition when doing lon-term validation or specification setting in multiple markets?”

Process map for change control, validation, regulatory and disposition

Perhaps it is a cleaning validation, or a major process change, or a new filter or raw material. You need to be able to disposition product against a change control to some markets but not all.

It is important to realize that changes become effective at multiple times. Looking back on the post “Changes become Effective” we are managing after change-in-use where the regulatory approval is not being simultaneously gated and product will be sent to market on a case-by-case basis.

The change control contains a corresponding regulatory assessment with required variations for all impacted markets, and a disposition strategy aligned with validation activities. With action items (e.g. work, tasks) in the change control for ongoing evaluation of lots impacted by study.

That disposition strategy might include evaluation of data vs acceptance criteria for each lot via checklist (or other tool) included in disposition packet; or an evaluation of data through change control task and disposition references change control. They are pretty similar in results and it more ends up being a record management preference.

High level match between regulatory and inventory