July 28, 2015

Should FDA Get Tougher on IRBs?

Patrick Stone

Patrick Stone, President, TradeStoneQA

The FDA says IRB’s (Investigational Review Boards) are not required to collect a statement of investigator assurance from studies they preside over.

This is troubling. My first question would be how are IRB’s going to assure clinical investigators will abide by requisite 21 code of federal regulations (CFR) and the sponsor approved protocol? How will IRB’s ensure that the protocol they are approving is authorized by FDA for human clinical trials?

fancyFDAlogoClinicaltrials.gov is a great repository and can be a big help here, but only if it used by the IRB’s and updated in a timely manner. In my day as an FDA inspector [1998] we were trained that IRB’s are FDA’s eyes and ear’s because FDA is not going to get to very many clinical investigator audits. Fewer than one percent of clinical trials ongoing domestically are reviewed by the agency.

That’s why I’m a little worried. Why would FDA abandon a last line of defense for patient safety? I’m not sure why the agency takes this position, but luckily for patients, most IRB’s do hold clinical investigators accountable for all HHS requirements (FDA & OHRP) and even conduct quality audits for a small percentage of the clinical trials they preside over. If 21 CFR is the bare minimum requirement for compliance, wouldn’t additional IRB oversight be a big boost to compliance if FDA is not able to review a much higher percentage of the domestic ongoing clinical trials?

There’s another area of concern: A 2013 FDA guidance states that only sponsors and clinical Investigators need to keep track of financial disclosure documents. Financial disclosure should be reviewed by IRB’s especially institutional IRB’s that can easily verify if conflicts of interest exist for clinical investigators under their review.

But let’s save that topic for the next time!

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls

Russ King, Managing Partner, Methodsense

Russ King, Managing Partner, Methodsense

IEC 62304, the international standard that defines software development lifecycle requirements for medical device software, was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to develop software components. Conformance with this standard demonstrates that there is a software development process in place that fulfills the requirements of the Medical Device Directive.

If your medical device has software that regulates its functionality in a way that contributes to Basic Safety or Essential Performance, then you will need to comply with IEC 62304. This standard requires all aspects of the Software Development Life Cycle (SDLC) to be appropriately managed to ensure patient safety, including:

  • Development and code reviews
  • Risk management
  • Configuration management
  • Incident and bug resolution
  • Validation
  • Maintenance

dnachainThe most common mistake medical device manufacturers make is failing to assess which elements of risk their software mitigates. These are the elements that must be addressed by IEC 62304. For example, what would happen if the creator of a hoist didn’t properly vet the software that signaled the hoist to lower the patient at a certain speed? If a patient were lowered too quickly – or not at all – there would be a risk management nightmare. Since software plays a role in the Basic Safety functions of the hoist, it must comply with 62304’s requirements.

Common software functionality manufacturers fail to recognize as IEC 62304 compliance issues include:

  • Alarms and Alerts often an Essential Performance requirement because they are intended to detect abnormalities
  • Speed & Position Sensors use of software to limit range of motion, speed and force, which are Basic Safety concerns
  • Algorithms remove the software and the device is no longer able to operate as intended, resulting in the algorithms being part of Essential Performance 

It is critical to have clearly defined processes for your company and your Software Development Life Cycle, in particular. IEC 62304 identifies several expectations related to the information that should be included in your SDLC procedures, including:

  • Documentation of your process – document management is essential for meeting compliance goals
  • Software of Unknown Pedigree (SOUP) – manage your SOUP appropriately
  • Document Development – make certain you are sufficiently resourced to support document development needs
  • Version Control & Updates – clearly define software updates and how software will be maintained in a validated state.

Medical device manufacturers frequently seek 3rd party software development assistance. However, the manufacturer remains responsible for the device software. Important areas to consider when contracting out your software development include:

  • Supplier Management Processconfirm that your software vendor complies with IEC 62304 and their processes are reviewed during vendor audit
  • Quality Agreement – confirm that:
    • It defines vendor responsibilities and IEC 62304 Deliverables
    • Vendor procedures used for software development will be provided to you and the test lab for review
  • Establish your SDLC – at minimum, your process will define acceptance criteria (i.e. IEC 62304 compliance and deliverables) from your vendor

Once you know you must comply with IEC 62304, how do you go about preparing? To start, know that compliance with this standard is defined as implementing all of the processes, activities and tasks identified in the standard in accordance with the software safety class. 62304 itself does not prescribe a particular organizational structure or specific format for documentation. Compliance is determined by a review of all required documentation, including the risk management file.

IEC 62304 file will be reviewed to ensure:

  • It contains all required documentation including a risk management file
  • Procedures meet the requirements of the standard
  • Each check list item is satisfied
  • A product review is conducted and further a review of the relevant software segments if it has been decided that the software performs Basic Safety or Essential Performance for your device

If you get caught in any of the above-mentioned pitfalls, you’ve probably got a problem. You will either not receive a report at all, or will receive a report that says you failed somewhere in IEC 60601-1 or IEC 62304.

Because the standards are voluntary in the US, you don’t necessarily have to make product changes. However, for each “fail,” you will be required to provide justification for each deviation. If you have valid justification, your device should still attain regulatory approval from the FDA, although developing this justification can be a lengthy process in itself. In the end, though, you may find it more efficient to comply with IEC 62304.

Download your IEC 62304 action list here. 

Russ King is President of Methodsense, a consulting firm that helps clients deliver medical and technological breakthroughs by effectively meeting the requirements needed to bring their products to market. He can be reached at (919) 313-3962 or rking@methodsense.com.

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FDA’s Action Plan Demands Some Industry Action, Too

Patrick Stone

Patrick Stone, President, TradeStoneQA

“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed by the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), and the Center for Veterinary Medicine (CVM), is intended to facilitate operational and program alignment as FDA transitions to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, and well-designed and coordinated implementation.

That’s the FDA’s plain Jane version of its 2015 Action Plan. But let’s look at some interesting wrinkles not necessarily contained in the document.

The Pharmaceuticals Inspectorate will change the way FDA inspectors conducts audits and how many audits will be conducted in a years’ time. There are some interesting things to note here: First, the Center for Biologics (CBER) is noticeably not included in this reorganization effort. Second, district offices will not be at the helm when it comes to which drug firms get inspected and how compliance OAI & VAI cases are handled. Third, CDER will be assuming the lead role and Center compliance teams will be responsible for industry corrective action plans.

prescription drugsTraditionally, the district compliance team for the drug company took the lead role in compliance strategy and remediation. But now, the inspectors conducting drug audits will be dedicated and certified to conduct inspections. This will reduce errors and enhance the quality of inspections domestically and internationally. This will also increase the number of observations (483 notice of observations), warning letters, and consent decrees.

When a generalist inspector conducts a drug audit they may miss a system wide failure or process control deviation due to a lack of training. By contrast, when a professional team of inspectors with dedicated drug training for a drug firms system conduct an audit, those same compliance issues are not usually missed. This is a positive step in the right direction however building the new drug teams and training them accordingly will take years.

Quality by design (QbD) implementation is looming so this will also affect the training requirements from a system based approach to a QbD approach.

Don’t be caught off-guard by this new way of doing things. The FDA is making some changes here, and regulated firms need to make sure they understand them.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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FDA Works to Clarify Device Data Collection Priorities

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms uncertain if post-approval studies can replace premarket studies at the time of approval for premarket approval applications (PMAs).

The agency says there are some instances where it may consider it acceptable to collect certain data in a postmarket setting rather than premarket.

FDAlogoOne area is mature technologies. For example, a subcutaneous implantable cardioverter defibrillator (S-ICD) has the same basic elements of an ICD, which have been used for decades. Clinical and preclinical evaluations in the premarket setting for the subcutaneous ICD were tailored to collect data on the new aspects and to evaluate functionality of the device, while more detailed safety data is collected in a postmarket study.

Other situations include an urgent public health need, especially in a situation where postmarket testing would do a better job confirming the benefits of a device.

The guidance spells out several other examples where it may be appropriate, including:

  • Migration, an approach used when approval of Class III in vitro diagnostic devices previously approved, licensed, or cleared assay is shifted to another system for which FDA hasn’t evaluated assay performance, is suitable in cases when sufficient knowledge can be gleaned for the documentation of design controls, risk analyses, and prior performance studies on an already marketed system.
  • Confirmation of mitigation effectiveness for a known risk in a post-approval study.
  • Modifying warnings, contraindications, and/or precautions in approved labeling.
  • Approval for an intended population beyond what was fully evaluated in the pivotal trial, with a confirmatory post-approval study.
  • Assessment of long-term performance in a post-approval study.
  • Assessment of rare adverse events in a post-approval study.
  • Confirmation of bench data with clinical data collected in a post-approval study.
  • Where the performance of a particular device type is well-studied, documented, and understood
  • Where long-term outside the U.S. clinical performance data is available but deemed insufficient.
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FDA Plays Catch Up In Brave New World of Electronic Consent

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool which promises faster, cheaper access to potential trial participants, and unimagined data streams to boot, the guidance comes at an important time for the clinical trial world.

Never accused of being early adopters of technology, clinical trial folks need to heed the FDA’s new guidance. Used properly, it can serve as something of a roadmap as everyone veers into previously unchartered territory.

First, understand the FDA’s expectations as laid out in the new guidance. It expects subjects to receive enough information to allow for an informed decision and an easy way to ask questions and receive jargon-free answers.

When using an eIC, FDA requires it to contain all elements of traditional IC, but also that any interactive eIC program be easy to navigate, including the means for the subject to stop and return to it later. Further, eIC tools must meet any subject’s physical limitations, e.g. poor vision or impaired motor skills. Perhaps most importantly, the eIC “must be presented in a manner that minimizes the possibility of coercion or undue influence regarding the subject’s decision to participate in a study.

FDAlogoFDA requires an investigator to obtain the informed consent. However, if the investigator delegates the responsibility, it is their obligation to hire a surrogate with demonstrable credentials. Nothing new there. But it gets a little more complicated when it comes to eIC. For example, consent can be handled remotely. However, when the consent process is not personally witnessed by study personnel, the eIC should include a method to ensure that the person giving consent is the person participating, or the subject’s legally authorized representative. The subject must also have the opportunity to ask questions and receive answers before actually signing electronically.

A subjects’ questions can be answered in a number of ways, including text message, phone calls, and videoconferencing. The data and communications must be secure. Subjects should also be told in advance how and when they will receive answers to questions and given information on how to contact an appropriate individual with questions about the investigation, the subjects’ rights and whom to contact in the event that a research-related injury occurs.

FDA also issues some eIC direction to IRBs. “A critical part” of an IRBs responsibility is to ensure that there is an adequate informed consent process in place that protects the rights and welfare of subjects participating in clinical investigations. Further, the agency recommends, but does not outright require, that an investigator discuss plans for using eIC with the IRB before finalizing development of the eIC to ensure that the IRB agrees that a particular format may be used for obtaining informed consent.

The FDA remains neutral when it comes to archiving documents. That said, the agency does weigh in on “cloud” and other remote storage solutions. Data privacy laws and regulations that apply to the remote site, in addition to those that apply to the research site itself, “may apply and should be considered.”

Finally, the agency reminds us that when one of its cheerful investigators is waiting in your lobby, he or she will be expecting access to records and reports made by the investigator including site-specific versions of eICs, materials submitted to IRBs for review and approval, all amendments to the site-specific eICs, and all subject-specific signed eICs. Any updates to the documentation must also be available for review.

Comments on the guidance are due May 8. When submitting your input, refer to docket no. FDA-2015-D-0390

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Brookings Looks to Advance Medical Device Postmarket Surveillance System

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Patients and medical device innovators will benefit if the United States is able to launch a National Device Postmarket Surveillance System (MDS), says a new report by the Brookings Institution with input from a wide swath of public-private players including the Office of Surveillance and Biometrics Center for Devices and Radiological Health.

The Brookings paper, “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,” calls for an MDS that’s responsible for coordinating medical device postmarket evidence activities, then builds and facilitates access to a network of data partners. The report also stresses, however, that the MDS should not work in a vacuum. Instead, it should be built upon and coordinate with existing public and private sector programs to better leverage existing expertise and resources.

Brookings envisions a system that collaborates with other groups to support other high-priority evidence needs that may benefit from the same infrastructure, including product tracking and utilization, clinical quality improvement, and economic analysis of medical device-related care.

medicaldeviceThe Brookings Planning Board (PB) suggests the new MDS be implemented and managed by a wide array of stakeholders. But none of this is going to happen overnight. The PB envisions a seven-year rollout, with the first two years devoted to an incubator project tasked with developing a five-year MDS implementation plan.

Ideally, the incubator project would be initiated by the FDA. The report lays it out pretty clearly. “Without some initial seed funding and active FDA engagement, it will be difficult to assure the purpose and sustain the momentum necessary for other stakeholders to fully engage in the development of MDS.”

Finding funds won’t be easy, the report authors acknowledge. For example, the FDA does not currently have any specific appropriations dedicated to paying for the initiative. Congress enacted legislation in 2012 mandating the agency expand the Sentinel system to include medical devices. Unfortunately, folks on Capitol Hill didn’t come up with or identify other sources for the cash to fund it. The PB calls for “more explicit Congressional support” to support and fund the infrastructure required to emerge with a robust system of medical device surveillance in this country.

While Washington’s culture of gridlock isn’t exactly encouraging, maybe the prospect of safer medical devices developed in a climate that encourages innovation is the kind of thing a few of them can actually support on the same day. We’ll see.

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FDA Gives MDDS World a Big Break

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Sometimes it’s nice to be told what the FDA isnt going to do. The agency issued a guidance last month that should give anyone building or working with a Medical Device Data System (MDDS) happy and relieved. Can you hear the collective sigh?

FDA defines MDDS as any hardware or software that transfers, stores, converts, and or/displays medical device data. To be considered MDDS, the product cannot modify either the data or its display. It also cannot, by itself, control the functions of a medical device. MDDS is not supposed to be used for active patient monitoring. FDA’s MDDS examples include:

  • software that stores patient data such as blood pressure readings for review at a later time;
  • software that converts digital data generated by a pulse oximeter into a format that can be printed; and
  • software that displays a previously stored electrocardiogram for a particular patient.

FDA logoThe February 9 guidance, building on a June 2014 draft document, advises manufactures, distributors and others involved that it “does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices.” Industry should thank the FDA for acknowledging the low-risk nature of such devices. Further, the agency cited the “importance they play in advancing digital health.”

Specifically, the agency is giving out three free passes: MDDS previously subject to 21 CFR 880.6310, medical image storage devices previously subject to 21 CFR 892.2010, and medical image communications previously devices subject to 21 CFR 892.2020.

Comments, or applause, can be sent to the agency at www.regulations.gov. Cite document number 140021. The agency does point out, however, that comments may not be acted upon until the document is next revised or updated.

Stuck for a comment idea? Well, flowers are always nice. People love those big tins of caramel popcorn, too.

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FDA CDRH Enforcement: Agency Eases Up a Bit at Home, Looks Overseas

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Quality system surveillance inspections dropped about 3% in 2013, the FDA’s Center for Devices and Radiological Health (CDRH) says in its latest stats. It’s not sure why, exactly, but posits it’s due to an increase in inspections overseas. That drains away resources for domestic doings.

It’s worth noting that the overall number of inspectional observations dropped by 17 percent in FDA’s latest stats from 2013. FDA’s most frequent inspectional observations remained consistent, with Corrective and preventive action procedures (CAPA) leading the way, followed by complaint reviewing, receiving and evaluating. The trio was rounded out by problems with quality audits to assure quality systems are in compliance. Not much new there. Still, it’s important to know.

For the first time since 2009, the number of warning letters issued by CDRH dropped according to the agency’s most recent annual stats. Fewer than 5% of domestic firms and over 15% of foreign firms inspected received warning letters. That might sound good to US-based device makers, but as manufacturing moves more and more overseas, those higher stats are becoming their problem, too.

FDAlogoUntil we receive more recent numbers, we’ll have to look for anecdotal evidence suggesting any deviation in the FDA’s regulatory focus in 2014 or 2015. So far, it’s looking like business as usual.

Let’s take a quick look at some recent warning letters to better illustrate the point:

While FDA’s overseas inspections have tended to focus on India and China, CDRH hit Spanish-based DIMA, a manufacturer of slings and incontinence mesh products, with a warning letter for insufficient environmental controls and other good manufacturing practice (GMP) shortcomings. CDRH hit the form for not having change handling procedures that were up to the mark, and failure to demonstrate that a CAPA it opened ultimately did not require corrective actions.

Back in Tonawanda NY, CDRH’s January 23 warning letter to Praxair criticized the firm for not having clear definitions for what qualified as a reportable event. Further, the agency said the company did not require verification of validation of CAPAs. Praxair makes gas flow products that regulate oxygen flow.

Related:

FDA FastStats: A Look Back at 2013 Medical Device Warning Letters and Quality System Deficiencies

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Training Management Best Practices for Emerging Life Science Companies

Jeff Mazik

Jeff Mazik, Vice President, Life Science Solutions, AssurX

No matter how good your written policies are, or how clean a facility you operate, or how successful you are in the marketplace, it can all fall apart without a strong handle on your organization’s training needs and ability to effectively manage a training program. Ensuring that your staff is properly trained to do their work is a basic expectation for regulatory bodies in the life science industries. In order to manage this extremely important activity, your organization must:

  • Properly identify and maintain training requirements
  • Manage all associated training activities
  • Identify, provide, and manage training materials and locales
  • Be able to successfully report on an individual’s training history
  • Ensure outstanding training needs are being completed in a timely manner
  • Ensure training is effective

Implementing a best practice solution for training management is essential to help an emerging life science company ensure compliance and quality. Regulatory agencies in the life science industries demand that your company has proper controls in place that ensure your staff, employees and non-employees are properly trained, that their training is documented, and that changes that require re-training are properly maintained, communicated, and rolled out, resulting in auditable documented training.

trainingblogUtilizing an electronic training management system is preferable, but regardless of the system, there are a few things one must begin to compile to be ready to implement a structure that helps a training organization or human resource staff successfully manage training. Another important goal here is the ability to create an environment where a change to a training requirement results in an immediate and logical set of training tasks to be assigned to affected trainees. This is essential in ensuring ongoing quality within your organization’s training environment.

So how does one begin creating such an environment? The first step is understanding your own organization’s training landscape. Your organization has a number of people, each may play multiple roles (this is especially true with start-ups), and, as such, each role has its own training needs and requirements. Also contained in this landscape are many training elements that need to be managed. These include documents and courses that might be required. You will need to gather this information and get it into a structure that allows the easiest management as changes occur. Also, it is imperative that you have a good idea of how changes will be handled as they will inevitably occur and also to identify how these changes will be communicated.

Once you have a good understanding of your current landscape, the next step is to follow a four step process to identify and structure the data so as to be ready to manage the training for your organization. Let’s take a look at each step:

  1. Requirement Building. The goal of this step is to identify and document all training elements (documents and courses) that are required to achieve a specific requirement (e.g. Manager Requirements, Sterile Cleaning requirements, General Human Resource requirements, etc.)
  2. Role Identification. The goal of this step is to identify the roles/major activities that are present in your organization (e.g. Shift Manager, Line Operator, Employee, etc.)
  3. Role-to-Requirement association. The goal here is to take the defined requirements, and assign them to the Roles identified. Note that some roles have multiple requirements to complete. For example: the “Shift Manager” may have both the “Sterile Cleaning” requirement and “Manager” requirements assigned to him/her
  4. Identify employee’s role(s). The goal here is to assign the identified role (or roles) to the individuals, showing which roles they perform for our company. (For example, John Smith serves in the “Shift Manager” and “Employee”)

When completely implemented, if a new training document (for example) is added to a requirement, all employees whose role incorporates that requirement will now be required to be trained. Or if a person changes roles within an organization, the act of assigning that role to that person will trigger the need for new training and assign it to that person.

This four step approach provides you with a very powerful way to manage training in your organization. It helps you organize training by roles for an employee or contractor, but it also helps you organize requirements for those roles. In effect, you are now able to manage your complete employee and contractor training in a grouped fashion.

Importance of Automation:

At first glance, to manually manage these lists in a spreadsheet or other common office tool can be very overwhelming. That is where implementing a training management solution, configured to handle training management particularly, helps out tremendously. Advantages of using a training management solution include:

  1. Immediate email notification whenever new training is required (triggered by adding or changing of roles, requirements, courses, or documents)
  2. Ensure timely staff training (due dates tracked and charted, reminders sent)
  3. Ensures appropriateness of staff training (only those affected get training notification)
  4. Easily manage changing training requirements
  5. Quickly identify “who-needs-what” training
  6. Easily identify outstanding delinquent Training and escalate to management, if necessary

Plus, there are many advantages if the training management system is integrated within the company’s document management system. Examples include:

  1. Automatic training notifications generated as a document revision becomes available for training
  2. Overall paper reduction
  3. Ensures user is accessing and training on the current version of the document
  4. Training documents can be provided online via a “click” (potentially minimizes users need to hide old versions of documents)

Bottom line: if implemented accordingly, using this four step approach within a best practice training management system results in an environment where people are trained to do the job they have been hired to do.

Note on resources:

Many start-ups and emerging companies in the life science industries are constrained in a number of ways — notably in funds and resources. This can present many hurdles in trying to get a useful training management system in place. In order to minimize costs and expending copious resources, some options to consider include: selecting a solution that can effectively address multiple business or quality needs to increase ROI, a solution that provides a lower cost option of hosting off-site (e.g., cloud-based solution), one that utilizes non-proprietary infrastructures, and one that can be configured without requiring programming resources.

Other items to be aware of:

A best practice approach for implementing an electronic training management system also includes these other important attributes. They are true needs that best of breed quality management systems will provide:

Communication: Automatic assignment of training when requirements change and then communicates those assignments effectively.   Notification to users of coming-due uncompleted training tasks, and course registrations.

Client experience: The electronic system should incorporate end-user functionality that increases performance and acceptance such as: including built-in instructions within the process itself as well as visual hints or cues that make it obvious to the user where the document is in the process and what to do next. Also, it’s preferable to use dashboards displaying only data pertinent to the user.

Control: As with any validated system, changes to the process need to be controlled and managed under change control procedures. Also, control of business processes is key. The system should provide seamless integration and flow to other quality and/or business processes, such as to document management, or to provide CAPA generated re-training tasks.

Compliance: The electronic system must meet all applicable regulatory requirements (e.g. 21 CFR Part 11). Also, implementing reminders and escalations when tasks are due (or late!) helps you to stay in compliance to objectives and agreed upon timelines.

Configurability: The solution you use should be easily configured, maintained, and updated, breaking you from a strong reliance on costly programmers, consultants, and specialized IT resources to make a change or to add a step to the process.

The above is a summary of a Webinar conducted recently titled “Training Management Best Practices for Emerging Life Science Companies”. If you are interested in getting more details Training Management Best Practices and to view a demonstration of a Web-based solution that meets these best practice elements, please request a replay of the 60-minute Webinar here.

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Quality Takes Time, FDA’s CDER Reminds Drug Makers

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the Fifth Century B.C. and the Sixteenth Century A.D.. The Great Pyramid of Giza took about twenty years to construct, according to ancient historians, but it must be remembered that Egypt’s rulers were pretty rough on their non-volunteer workforce. Deadlines had a deeper meaning back then.

By contrast, the Center for Drug Evaluation and Research (CDER) quality initiative has been with us some ten years, or about the time it took to build the Panama Canal. Both projects have had to dig through – and around – a lot of muck. At the peak of work, excavators in Panama carved out the equivalent of the English Channel Tunnel every 14 weeks. It’s not fair to hold the agency to that same standard.

Pharmaceutical manufacturingInstead, let’s acknowledge that FDA just completed its own new structure called the Office of Pharmaceutical Quality (OPQ). Less bricks and mortar than a shift in human capital, the OPQ will take on some of the functions and staff at the Office of Pharmaceutical Science (OPS), take some preapproval and surveillance inspections duties from the Office of Compliance (OC), and absorb some of the inspection-related activities for bioequivalence/bioavailability and non-clinical studies from OC’s Office of Scientific Investigations. The idea is to make the drug review more integrated with FDA and improve communications both ways.

The agency hopes OPQ will streamline the processes that monitor drug quality throughout the product lifecycle, including drug application review, post-approval improvements, and surveillance and inspections of global manufacturing facilities.

OPQ was built, in part, in response to the falling number of drug-related product recalls over the past few years. FDA believes OPQ will help it better organize and quantify the state of manufacturing at drug facilities in the US and abroad. FDA’s recently been pushing a new approach to quality metrics, as highlighted by CDER’s Russell Wesdyk. His presentation outlines CDER’s revised way of looking at surveillance and adoption of quality metrics that promote the use of a common language to improve measurement.

According to Wesdyk, quality metrics will be used to assist segment sites and producers based on risk when it comes to inspection and reviews. But it won’t issue “restaurant style grades” reporting how one facility stacks up against industry groupings. Wesdyk encourages any interested parties to reach out to him as FDA’s thinking evolves. That’s a good thing.

Remember, it’s not as if the Panama Canal doesn’t require some maintenance now and then. The FDA’s got the right idea here.

The alternative is to build something and then forget about it. We’ve all seen how that usually turns out.  Take a look at the Pyramid of Giza lately?

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