Top Ten Ways to Make GMP Training Relevant

Most GMP training that I encounter is not necessarily bad--just irrelevant. In fact the same could be said for the Training Department. They jealously guard their turf and deliver mediocre, perfunctory training. Names get checked off the list, and the Training Department goes about their business being irrelevant. (Ouch!)


There is nothing that could be more exciting and fulfilling than being part of a dynamic training group that equips its organization to be a finely tuned work force of scholars that embrace GMPs as a business enabler.


Unfortunately, rather than a graduate education in the pharmaceutics of regulations, our best and brightest are subjected to a mind-dulling deck of tired old PowerPoint slides.


Frankly, the problem is endemic and here's why:

1. The concepts are not applied to the real world. We herd the mignons into the cafeteria and deliver the obligatory annual GMP training with total disrespect for what each employee does as part of his/her job everyday.

2. Training topics are not strategic. The lack of the broader view of the state of the industry and regulatory enforcement trends keeps GMP training from being proactive or responsive to the changing regulatory environment.

3. Training is not data-driven. The topics selected are often disconnected from the problems at the site as revealed at quality metric review forums such as Quality Management Review.

4. Training is the ubiquitous excuse (punishment) for corrective and preventive action. The easy out is to say that a failure can be addressed by training without truly determining the root cause.

5. The training method is not effective. When everything from a step change to a total system re-design is handled by "Read and Understand," it is difficult to distinguish between minor and really significant training topics.

6. The trainers are dreadfully boring. It's amazing how much we devalue the importance of training as evidenced by the little emphasis we place on the design and delivery skills we place on the people we put in those positions.

7. Lack of attendance is tolerated. When there is a conflict in one's schedule, the training class is always the loser. Nothing ever happens if you don't attend, because usually know one knows. No one really cares.

8. Leaders don't go to training either. It's comes down to not really expecting leadership to be trained, as though there is some special dispensation with the privileged class. They certainly aren't examples to follow.

9. The priority of the production manager is getting product out the door, not the skills and capability of his/her workers. In fact, he/she may be totally unaware of whether the workforce is getting the right training, or current with meeting individual training requirements.


10. Measurable improvement in skills and knowledge is not rewarded. We reward what we value, and training isn't it.


So, class, here's your assignment:


Turn each of these negative statements into a positive one. Then perform a self assessment of your organization against these statements.


Don't be defeated if the results are pathetic. You are in good company. It's all about what you do with the information starting right now. 


Turn these into vision statements. Discuss the practical, measurable steps you can take to improve the relevance of your GMP training.


Keep it going, and watch amazing things happen!



The QA Pharm

Where were you on September 11? Let us never forget.

I remember exactly where I was and exactly what I was doing on September 11, 2001. The time and place have been indelibly etched in my brain.

It was Washington, DC where I heard the announcement. I heard the sirens and saw the army helicopters fly overhead and patrols of army vehicles in the street. It was am image of a city under siege. The burning, crumbling Twin Towers and the caved-in Pentagon were replayed on the news channels. Eventually the reality of it all sank in--our homeland was attacked.

Then the news came out about Flight 93 downed in Shanksville, PA. "Let's Roll" became the rally cry of my personal heroes onboard the plane that fateful day. I was within spitting distance of the Capitol Building at the time, the likely intended target.

I passed many makeshift memorials on my walk to the train station for my failed attempt to find transportation to just about anywhere. The Capitol flag was at half-mast. People milled about. Strangers talking to strangers. I felt anger and pain for our country.

The memorial service at the National Cathedral was going on in the Admirals Club the day I was able to fly out of Dulles. Travelers turned their chairs to face the television. Little-by-little the club turned into a sanctuary. There were tears. There were prayers.

Nothing would be the same, other than our resolve to not to let our enemies take away our lifestyle. I felt a surge of patriotism and a sense of duty, and I knew that I would never be the  same.

So in honor of September 11th and all those who gave their lives--and my heroes buried among the ashes in Shanksville--I am getting on an airplane.



The QA Pharm

Decisions and Indecision—The Organizational Vortex

The cover of Fortune magazine popped off the newsstand shelf last week: What Happened at Pfizer: The Inside Story of Revenge, Betrayal, and Power at the Top of the World’s Largest Drug Company.” (August 15, 2011)

Amidst the story that recounted epic boardroom intrigue, one section described the impact that these political shenanigans had on day-to-day decision-making.

“A second anonymous letter, claiming to be from ‘responsible, long and loyal Legal Division employees,’ arrived on the very day of the board meeting. It complained of ‘micromanagement,’ ‘constant’ internal reorganization, and a ‘chaotic’ decision-making process. ‘A decision is made, then reconsidered and changed. Decisions, even minor…are picked apart and often directed to be undone. Then re-studied. Then the decision-making group expands. Paranoia results. Autonomy is sapped.”

When it comes to fuzzy authority and recycled decisions, Pfizer is not alone. Wherever it occurs, at whatever level, the organization is seriously impacted. It matters how decisions are made. Nothing is more revealing about the leadership and the future of an organization than how decisions are made.

One of the most fundamental responsibilities of top management is to align the organization—to get all the oars of the scullers in the water pulling in the same direction. When company leaders compete for the megaphone it becomes, “Stroke, no don’t stroke. Pull left; I mean right—now, anyway.” The course is convoluted, not straight; energy is wasted, not conserved.

When there is leadership dysfunction, there is organization dysfunction and ultimately the patient suffers. Yes—the patient.

Whether it is getting the organization aligned to resolve its regulatory compliance problems, or on time order fulfillment, it is clear lines of authority and crisp decisions that lead us across the finish line.

So, if you feel sometimes you are in an organizational vortex of ineffective decision-making, my recommendations are these:

1.    When you accept an assignment, be clear about who are the reviewers and approvers. A good Responsible, Accountable, Consulted, Informed (RACI) model applies here.

2.    Establish a charter with a clear scope, lines of communication and decision-making authority. Have your oversight committee approve.

3.    Before you are asked to present to your oversight committee, be sure to clarify whether your authority extends beyond recommendations to decisions. If you are the decision maker, walk the committee through your logic.

4.    Clarify what decision was made. After the presentation to your oversight committee, sum up the decisions. Don’t leave until every decision is crystal clear.

5.    If you were charted with decision-making authority, but your oversight committee takes it out of your hands in a meeting, ask for an explanation. Otherwise, you have no basis of moving forward.

6.    Capture minutes of decisions. Whenever you sense that you are having a “Groundhog Day” meeting, remind the participants that the issue had been discussed and decision had been made as recorded in the minutes.

7.    If anyone on the oversight committee starts to lobby outside of the committee to change the decision, stop it dead in its tracks. Indicate to that person that the decision was made.

8.    When you detect dissention among those of equal authority and it impacts your ability to make progress, meet with them collectively with the stated objective to achieve unified direction.

9.    Document a decision timeline. Nothing points to the effect of poor decision-making than a timeline of direction, redirection, and reverse direction. You may need it when you are asked why your project is behind schedule.

10. Protect your team from the effects of poor leadership decision-making. Make forward progress where you can; assume you make the decision. Resist all temptation to promulgate the organizational vortex.

Don’t be the victim of a dysfunctional environment. You may not be able to take complete control, but you can take steps to minimize its effects.

The QA Pharm

The Top Ten Warning Letter Observations about the Pharmaceutical Quality Unit

The responsibilities of the Pharmaceutical Quality Unit are defined in the CGMPs and practices clarified in guidance documents. (See The QA Pharm, August 7, 2011.)

Just as it is with any legal matter, case histories help us understand how the law is applied in specific situations. That’s the reason it is a good practice to regularly review Warning Letters on the FDA website.

Here’s my condensed list of issues the FDA has had with the Quality Unit as seen in Warning letter observations.

This is the list you don’t want to be on.

1.    QU failed to establish a system to ensure that…[fill in the blank for anything that went wrong]

2.    QU failed to document the responsibilities applicable to the quality control unit in procedures, and fully perform these responsibilities.

3.    The personnel performing laboratory tests… were not trained.

4.    QU failed to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.

5.    QU failed to fully perform and/or document the review of batch production records to determine compliance with all established, approved written procedures before a batch is released or distributed.

6.    QU failed to ensure that all tests are in conformance with the established specifications and that these are met prior to the release of drug products for distribution.

7.    QU did not review production records to assure that no errors had occurred or, if errors had occurred, that they had been fully investigated, conclusions made and followed-up.

8.    QU failed to investigate complaints involving the possible failure of a drug product to meet any of its specifications.

9.    Failure to submit NDA-Field Alert Reports (FARs) within three (3) working days of receipt of information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug products

10.  And my personal favorite…a designated QU has not been established.

The QA Pharm