Putting an effective complaint and recall management system in place

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of their users.
In the context of medical devices; complaints are any communication made in writing, electronically or in verbal form about any of these aspects of a medical device after its release for the purpose of distribution: identity, quality, durability, reliability, safety, effectiveness, or performance
FDA and ISO standards

The FDA has a very clear and well-defined set of regulatory guidelines on complaint handling in the field of medical devices. These are set out in FDA 21 CFR 820.198. The FDA requires medical device companies to also comply with ISO 13485:2016 Section 8.2.2., which suggests what document procedures to put in place to ensure timely handling of complaints in a compliant manner. Just how seriously the FDA takes complaint handling can be gauged from the fact that deficiency in complaint handling is one of the top reasons quoted for issuance of 483’s by the FDA.
Although complying with these regulations is a part of regulatory requirements; these regulations only mention what needs to be done in order to maintain a complaint and recall management system; how to do it is left to the individual medical device company. These regulations specify the exact elements of a complaint handling system, such as maintaining complaint files, proceeding about the complaints in a timely manner, documenting verbal complaints, and so on. However, it is up to the medical device manufacturer to implement the complaint handling and recall system in such a manner that it is perfectly streamlined and organized to the point where the complaint is handled exactly in the manner prescribed.
Full learning on how to implement an effective and compliant complaint and recall management system
The ways by which medical device companies can do this to optimize their complaint handling mechanism will be the teaching from a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. At this seminar, John Kasoff, Director of Regulatory Affairs, Life-Tech, Inc. and Principal Consultant at Lean to Quality, LLC, who brings more than three decades of experience in Quality and Regulatory management, during which he has implemented and overseen quality system operations and assured compliance, at all companies of all sizes, from start-up to more than $100 million in revenue; will be the Director.

Please visit Putting an effective complaint and recall management system in place to enroll for this seminar and gain thorough understanding of how to put an effective complaint and recall management system in place. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
An activity that cuts across many cross functions
Jeff will emphasize the point that complaint handling is a highly coordinated, cross functional area for a medical device company’s Quality System. Almost all niche areas of the medical device company, such as customer service, sales and marketing, Regulatory Affairs, QA, R and D, and Quality Engineering, are involved in complaint handling. This makes the need for orchestrated coordination and synchrony between these departments a must, for if the complaint handling mechanism is not well lubricated; it is bound to make the complaint handling act a failure, inviting all the undesirable penal actions from the regulatory and enforcement agencies.
John will highlight the role and importance of each of these functions in complaint handling. In these, activities relating to defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications, will be discussed in detail.
Distinguishing between complaints and “non-complaints”
He will also explain what constitutes a complaint, and will suggest recommended practice on the ways of handling “non-complaint” feedback. He will also show how to apply risk management to a complaint handling system, and explain a specific risk management system to drive home this point.
A substantial part of this seminar will be spent on making a streamlined review of the regulations, at which the critical process requirements for compliance with the regulations will be examined in detail. Jeff will offer straightforward and compliant recommendations for the methods of documentation relating to complaint records, root cause investigations, and corrective actions, and show how to apply risk management principles to complaint investigation.
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The science of Sad: understanding the causes of ‘winter depression’

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.
In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

Nobel prizes 2017: everything you need to know about circadian rhythms

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder
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Heart surgery survival chances ‘better in the afternoon’

Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.
The research, published in the Lancet, suggests the heart is stronger and better able to withstand surgery in the afternoon than the morning.
And it says the difference is not down to surgeons being tired in the morning.
Doctors need to stop the heart to perform operations including heart valve replacements. This puts the organ under stress as the flow of oxygen to the heart tissue is reduced.
The doctors and researchers looked for complications including heart attacks, heart failure or death after surgery. They found:

• 54 out of 298 morning patients had adverse events
• 28 out of 298 afternoon patients had adverse events
• Afternoon patients had around half the risk of complications
• One major event would be avoided for every 11 patients operated on in the afternoon

One of those involved in the research, Prof Bart Staels, from the Institut Pasteur de Lille, told the BBC News website: “We don’t want to frighten people from having surgery – it’s life saving.”
He also said it would be impossible for hospitals to conduct surgery only after lunch.
But Prof Staels added: “If we can identify patients at highest risk, they will definitely benefit from being pushed into the afternoon and that would be reasonable.”
Obesity and type 2 diabetes have been shown to increase the risk of complications after surgery.
Heart health is already known to fluctuate over the course of a day.
The risk of a heart attack or stroke is highest first thing in the morning, while the heart and lungs work at their peak in the afternoon.

 

Dr John O’Neill, from the UK Medical Research Council’s Laboratory of Molecular Biology, said: “Scientifically it is not hugely surprising, because just like every other cell in the body, heart cells have circadian rhythms that orchestrate their activity.
“Our cardiovascular system has the greatest output around mid/late-afternoon, which explains why professional athletes usually record their best performances around this time.”

• BBC Body Clock: What makes you tick?
• Body clock scientists win Nobel Prize
• Weekend camping resets body clock

Other possible explanations for the findings included surgeons being tired in the morning or their own body clock affecting their surgical skill, particularly if they are not “morning people”.
Read More: http://snip.ly/lr9h9#http://www.bbc.com/news/health-41763958

Analytical Instrument Qualification and System Validation

Analytical instruments used within a GMP environment need to be both qualified and validated. This is done because both the firmware that is used within the analytical instruments, as well as their software that comes into interaction with a play station that is situated adjacent to it, are computerized.

The guideline for analytical instrument qualification (AIQ) is part of the General Chapter <1058> within the USP. This guideline spells out the requirements for analytical instrument qualification.

Challenges of Analytical Instrument Qualification and System Validation

This said; the fact is that the USP 1058 simply sets out requirements for Analytical Instrument Qualification; while focusing on the instrument part of the validation process, it emphasizes very little on computerized system validation, which is also paired to the instrument, whose integral part it is.

The analytical instrument qualification, in turn, has its own guideline in the form of the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems. In particular, the second edition of this validation guide is focused almost exclusively on the computerized system, while very nearly ignoring the parts relating to instrument qualification.

Leads to confusion and half results

When analytical instrument qualification is seen as being disparate from the system validation, the result is that professionals are often confused and feel insufficient about which of these to use. So, analytical instrument qualification and system validation need to work in tango. While it is not advisable or safe to validate the computer system without first qualifying the instrument; the opposite is equally true.

A few instances of actions

Since late 2012, there has been added vigor in bridging and unifying the core aspects of AIQ and CSV. Some actions from different pharmacopeias and regulatory bodies of the world have aimed at achieving this objective. For example, in Europe, the new version of Annex 11 needs to be seen in combination with Chapter 4.

It is thus to be noted that only a combined approach to analytical instrument qualification (AIQ) and computerized system validation (CSV) will help professionals optimize laboratory systems using USP and GAMP.

Read More:https://www.linkedin.com/pulse/analytical-instrument-qualification-system-validation-ronald-gardner?trk=prof-post