A little knowledge is a dangerous thing, particularly when the underinformed individual holds a position of responsibility. To protect patients’ health, regulators require pharmaceutical manufacturers to train employees for their specific jobs on the plant floor. A company’s training-management system affects how quickly employees can get to work and helps a drugmaker demonstrate regulatory compliance. Paper-based training-management systems are well established in the industry, but they can create inefficiencies for some companies. 

 report asked Jeffrey Hartry, director of quality systems and information at Cangene (Winnipeg, Canada), about his company’s conversion from a paper-based to an electronic training-management system.

EPR: What problems did Cangene have with its paper-based training-management system?

Hartry: One was the overall management of the system. We went from a staff of about 325 to more than 800 over a relatively short period of time. Physically managing those records became more and more difficult with our growth, because the system wasn’t able to change or adapt as quickly as we grew.

That also brought in problems of consistency in terms of the documentation, which was managed in each of the various functional areas. Making sure that everyone knew what they needed to be trained on—and when—became a significant managerial exercise. Supervisors were responsible to ensure that their staff was trained—there was no direct, to-the-employee notification. 

The last of the challenges was with the paper-based system we were using for tracking when and what training had actually been done, and timely reporting the status of everyone’s training. Originally, we had only one record, which everyone signed to demonstrate that they’d completed the training on a given procedure. Since there was only one record, the training would often happen serially, not in parallel, which caused significant delays in documenting the training events.

EPR: What software did Cangene choose as its new training-management system?

Hartry: Our training-management package was a codevelopment between Cangene and Sparta Systems. Our training and development group had looked at TrackWise to see whether it could help remediate some of the challenges we had in tracking our training. The development of the workflows for training management in TrackWise were far more complex in structure than we had experience with. To their credit, Sparta Systems recognized the potential of the system and offered their development staff to help with the workflow.  In that process, we learned how best to approach our own training-management system and how to manage the volume of individual records at an employee level. 

EPR: How did the software improve Cangene’s training-management system and training programs?

Hartry: Most immediate was an overall improvement in the timeliness of required training events. The software has enabled us to see which individuals have been assigned training events, and whether they have completed their training within a given time. We’ve generated and deployed a standard training dashboard for every employee that lays out what training been assigned to him or her, when it is due, which training programs are coming due, and which ones are overdue. Each training event has specific links included in the training record that direct the employee to the documents they are required to be trained in.

The system has enabled us to thin out our training requirements by targeting specific functional groups rather than using a broad approach, which saw several programs rolled out to a larger-than-necessary user group. Significant groups of people were doing unnecessary training, and we were able to remove it from their requirements, saving time and resources. 

The system improved our ability to generate and provide reports on our training activities. When auditors come in and ask for reports, we have them typically within about 30 minutes. 

Training curriculums are now managed in a dynamic environment, so they can be changed more easily to reflect our needs. If an environment or requirement changes, we can adapt the curriculum and roll it out, typically within a week, to make sure that the staff is current. Overall, it’s improved our ability to be consistently compliant with all of our programs and processes. It’s been a tremendous benefit.

EPR: How did the new automated training-management system affect Cangene’s manufacturing operations?

It provided transparency. It allowed the supervisors to know, if there was a change in a batch operation, when or if the staff had completed the training on the change, and who hadn’t yet. It enabled the supervisors to make sure that before anyone actually entered into a manufacturing area, they’d completed all of the necessary training for that area and work, where previously in the paper-based system, where we were relying on supervisors’ memories and tracking tools to capture the status of employee training. We now have standardized reports that show where employees stand in terms of the training. You can call them up in about a half dozen clicks of the mouse.

Articles

Production Lines

Jeffrey Hartry, director of quality systems and information at Cangene (Winnipeg, Canada), talks about his company?s conversion from a paper-based to an electronic training-management system.

How to Remove the Paper Chase from Training Management

EMD Millipore
 Disposable bioreactor provides operational flexibility


 EMD Millipore’s (Billerica, MA) Enhanced Mobius 3L CellReady single-use bioreactor includes additional features intended to enhance its operational flexibility. The unit’s headplate now incorporates a septum injection port for small-volume additions. The bioreactor also incorporates a subsurface fluid inlet–outlet port appropriate for operations such as perfusion, sampling, cell retention, and inoculation. In addition, the Enhanced CellReady bioreactor includes a sensing port for monitoring parameters such as carbon dioxide and viable cell density. 

The CellReady 3L bioreactor exhibits cell-culture performance and physical-characterization properties (e.g., kLa values, heating profiles, and mixing times) similar to those of traditional glass bioreactors. EMD Millipore manufactures the device with lot-to-lot consistency to reduce the risks of improper assembly and help bring consistency to customers’ processes. The unit’s results can be scaled up to 15-L glass and 2000-L stainless-steel systems. The fully assembled, gamma-irradiated bioreactor has been designed to work with most existing benchtop bioreactor controllers.

Sartorius
 Instrument performs many filter-integrity tests


The Sartocheck 4 plus instrument from Sartorius (Goettingen, Germany) performs a battery of filter-integrity tests such as diffusion, bubble point, diffusion–bubble point, water intrusion, water flow, customer-specific bubble point, customer-specific diffusion, and multipoint diffusion. The operator can select the test program manually or use a barcode reader to enter data into test programs. When the operator scans a filter’s barcode, the instrument recalls the appropriate test program for that filter automatically. The tester can connect to a network and exports results as PDF files that can be shared easily with other data systems.

In addition, operators can prompt the tester to clean itself automatically in about an hour. Users add cleaning solution into a separate vessel, and the tester cleans, rinses, and dries its entire pneumatic path. Operators thus do not need to send the instrument to the manufacturer for cleaning, and this feature reduces downtime and cost.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2010 edition from EMD Millipore and Sartorius.

October 2010 Editor's Picks: Products from EMD Millipore and Sartorius

 Environmental monitoring provides additional assurance that a drug product has been manufactured in an environment of appropriate microbiological quality. This procedure is especially important in aseptic processing, which does not include terminal sterilization of the finished product. 

 Jeanne Moldenhauer, a recognized authority on environmental monitoring, has edited a series of books on the topic. Moldenhauer assembled a distinguished panel of experts to write the chapters that make up 

It is quite disappointing, however, to note the many shortcomings in the text, some of which are more serious than others. Although the book collects interesting chapters about environmental monitoring, it lacks an overarching theme or organization. If the editor had written an introductory chapter that linked the book's subtopics and explained the rationale for including them in the book, readers would have benefited. Moldenhauer also could have organized the sequence of chapters better so that a consistent thread ran through the book in a rational way.  

The book's emphasis on a risk-management approach to environmental monitoring, which is based on guidelines from the International Conference on Harmonization and the US Food and Drug Administration, also is problematic. The risk-based approach is a product of manufacturers' desire to reduce the cost of quality. It is a method of identifying risks and attempting to mitigate them or plan contingencies before the risks materialize. Personnel develop a risk-management program when their environmental-monitoring program is in the planning stage. If the environmental monitoring program detects unacceptable conditions, it can trigger contingencies.  

Each chapter that discusses risk management seems to show a grave misunderstanding of the subject. Risk management includes positive risks (i.e., opportunities) and negative risks (i.e., threats). The process includes the identification of risks, the assessment of risks, the prioritization of risks, the development of risk responses, and risk monitoring. Environmental monitoring is a small part of overall risk management. The authors add unnecessary complexity to the topic that could increase the cost of the environmental-quality program rather than decrease it.  

Parts of the book contain helpful information about risk management, however. For example, one author observes that environmental monitoring is not a risk-prevention tool, but a risk-monitoring tool. Chapter 8 offers an interesting discussion of risk management and of how personnel can apply various risk-management approaches to sterile production. The reader is directed to these discussions because they cover the topic more comprehensively than do the other chapters. 

 In addition to the book's broader problems, many chapters have their own particular flaws. The first chapter, titled "Designing and Validating a Contamination Control Program," contains abundant information that would fascinate a newly minted microbiologist. A veteran environmental microbiologist, however, is likely to find the chapter tedious because it covers many subjects that are not directly related to the chapter's ostensible focus. 

 The chapters that describe the "Lean Microbiology Laboratory" and that offer "Observations in Support of Lean Microbial Identifications" illustrate how Lean concepts can reduce the cost of environmental-monitoring programs. It is both unfortunate and timely that the authors cite Toyota for its Lean approach to quality in view of the massive quality problems that this approach seems to have brought the company. 

 The Lean laboratory likely will go the way of quality-control circles, which fell out of favor to be replaced first by Six Sigma, then by other alphabet-soup programs. The book extends Lean concepts to the various functions of the microbiology laboratory (e.g., microbial identification) through a discussion of standardizing procedures and protocols for identification. Because automated equipment and rapid methods have increased the productivity of microbial identification, companies tend to request the identification of more environmental microorganisms than before, regardless of whether the identifications are useful. The cost of identification using the Lean approach therefore will increase because it is based on the number of samples processed.  

Bengt Ljungqvist and Berit Reinsmüller, two well-known and respected environmental scientists, provided one of the book's best chapters, titled "Collection Efficiency of Microbiological Impaction Air Samples." This well-written and informative chapter increases the reader's understanding of the dynamic of air sampling using impaction samplers. But the chapter should have discussed the mechanisms of controversial air-monitoring systems such as settling plates because many laboratories use them.  

One chapter provides a sample of Warning Letters related to environmental monitoring that FDA issued between 2005 and 2010. Although the section is interesting, the author could have provided more context. A review of Warning Letters from the 1980s, for example, would have shown that companies are repeating the same infractions 

Chapter 10 is puzzling because it appears simply to be an unpaid advertisement for Sartorius's gel filters. A more appropriate inclusion would have been a comparative study of filters used in environmental monitoring. Data could have indicated to readers the value, strengths, and weaknesses of various filters for their intended purposes.  

The final chapter describes how to identify microorganisms through Fourier transform infrared (FTIR) spectroscopy. Despite the author's claims to the contrary, the technique is far from simple. It also might not be cost efficient because it requires skilled technicians and a large outlay of funds to purchase equipment. FTIR spectroscopy might not yet be ready for adoption by quality-assurance microbiology laboratories. 

 Unfortunately, the book does not live up to its description as a comprehensive handbook. It does, however, present valuable information. But the unfocused nature of this volume detracts from the main purpose of the series of books, which is the control of the manufacturing environment.  

is a principal consultant at Tri-Intersect Solutions and an associate professor of technology and engineering management at the University of Maryland, University College, Graduate School, College Park, MD 20742, tel. 301.762.9258, fax 301.762.5356, 

In the Mixer

An expert-panel-written book has surprising shortcomings.

Equipment and Processing Report-10-20-2010

How to Remove the Paper Chase from Training Management

October 2010 Editor's Picks: Products from EMD Millipore and Sartorius

An Unfocused Handbook on Environmental Monitoring