Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

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Good Laboratory Practice (GLP) differs from Good Manufacturing Practice (GMP) in a fundamental way. GLP deals with preclinical development, while GMP has to do with manufacturing. That is, while GLP concerns itself with study, GMP is all about the method, i.e., the process.

GLP are a set of regulations for conducting nonclinical laboratory studies, and are not a set of guidelines. GLP is covered under 21 CFR Part 58, and regulate nonclinical laboratory studies that support or intend supporting applications for research or marketing permits for certain classes of products. These include:

  • Food and color additives
  • Human and animal drugs
  • Medical devices for human use
  • Biological products and electronic products that are regulated by the FDA.

Joy McElroy, Principal Consultant at Maynard Consulting Company, will, at a marathon four-hour session being organized on March 25 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, explain all the aspects of GLP while giving clarity on how it differs from GMP.

Please visit globalcompliancepanel to register for this important learning, at which the following areas will be covered:

  • What are Good Laboratory Practices
  • Why were they created
  • What is the objective of GLPs and how are they associated with GMPs and SOPs
  • Statistical Procedures for data Evaluation
  • Instrumentation Validation
  • Analytical and laboratory Certification
  • Documentation and Maintenance of Records
  • Consequences of Noncompliance
  • Disqualification and Reinstatement

This webinar is being organized for the benefit of personnel that deal with GLP and GMP in the course of their work, and include Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel, and Auditors.

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About the expert:

With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

Medical Device Recalls – How to Handle in a Compliant, Diligent Manner

How to link these processes link to other parts of your Quality Management System. We’ll cover best practices so you can be prepared for a possible post-recall FDA inspection.

A Medical Device Recall (MDR) can be a handful to deal with. It not only indicates that the device has a quality issue; failing to address an MDR rightly can lead to loss of reputation, not to speak of regulatory penal actions from the FDA. It is up to the company whose device has been recalled, to take prompt, prescribed action. Its actions should be proportionate to the level of risk the faulty device poses.

An MDR should be planned well in advance, for it is not something that a medical device can handle hastily, in a piecemeal fashion. The ways by which to prepare for an MDR is thus a matter of crucial importance. GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will offer this valuable learning at a six-hour webinar it is organizing on October 28.

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Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the speaker at this session. To enroll for this webinar, please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-medical-device-recalls—how-to-handle-in-a-compliant,-diligent-manner-10304LIVE

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Even a high degree of preparation by a medical device company cannot completely rule out quality issues that result in a recall. There is no substitute for preparation. The objective of this webinar is to offer learning to its participants on how to prepare for an MDR. Susanne will explain how to decipher signals that could trigger a recall. She will also explain how to face the investigation and what actions are required, what corrective and preventive actions need to be taken, and how to send out notifications to customers and the regulatory bodies.

The expert will give a thorough understanding of the regulatory requirements for dealing with an MDR. She will help understand FDA expectations and regulations, and what to understand and learn from 483s and Warning Letters. The ways of putting robust processes, the basis to efficiently and effectively managing failure investigations, will be explained.

This webinar will also give a proper understanding of recalls, and explain the appropriate corrective and preventive actions that need to be taken. The ways in which these processes link to other aspects of the Quality Management System will be explained. It will give an idea of the best practices for making an MDR efficient. This will help participants prepare for a possible post-recall FDA inspection.

This webinar will have the following agenda:

  • Regulatory Expectations
  • Medical device authority and guidance
  • Complaint Handling, Medical Device Reporting, and Recall requirements
  • Recall Types and Classifications
  • Failure Investigation
  • Difference between a product enhancement and a recall
  • Roles and responsibilities
  • Non-conforming material control
  • Recall strategy and FDA notification
  • Required Communications
  • Firm’s MDR reporting and FDA’s handling of MDRs
  • Lessons learned and enforcement case studies
  • Processes and Procedures
  • Linkages between Complaint Handling, MDRs, Recalls, and CAPA
  • Corrective and Preventive Action
  • Minimize your risk of regulatory actions
  • FDA’s new guidance on risk
  • Preparing for an FDA Inspection

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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

Medical Device Recalls: How to Properly, Compliantly and Promptly Deal with a Recall

It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices. 

The Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to order recalls of medical devices, under certain circumstances (e.g., situations involving serious and immediate hazards to health) and controls.  With very few exceptions, device recalls by companies are voluntary.

There are three regulations promulgated by FDA that define their authority and the requirements applicable to device manufacturers and importers for the correction or removal-collectively known as recall-of medical devices; the requirements for these regulations are outlined in 21 CFR §7, 21 CFR §806, and 21 CFR §810. Each of these regulations is presented in detail in the following pages. Compliance with these three regulations also touches upon other regulations administered by FDA.

Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer. The number of device companies having their recall classified as a Class 1 (most severe) has surged in the past three years.  We will take the time to interact though the day to navigate all aspect of the recall process

This course will provide understanding recall compliance and the interrelationship on Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices.

Join Rita Hoffman, RAC an expert in the field of Post-Market Compliance.  Not only will you learn from her over her 40 years in both FDA as a Compliance Officer and Ombudsman, learning from her stories of what not to do, but you will take back a desktop manual on Post-Market reference guide.

Areas covered by the Instructor:

Determine what actions are taken in a medical device recall

  • Cite the regulatory requirements for recalls/ field actions regarding medical devices
  • Reference and use medical device recall authority and guidance documents
  • Identify and understand the applicable regulatory standards and guidance documents
  • Identify the different recall types and classifications
  • Explain what types of communications are required
  • Define what effectiveness checks are
  • Outline the steps required to terminate a recall and what regulatory reports and records are required for a device recall
  • Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
  • Firms MDR reporting and FDA’s handling of MDR reports
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
  • Walk-through of case examples
  • Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.

Why should you attend : Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

Areas Covered in the Session

  • Applicable and relevant regulations in EU, Canada and US
  • Definitions
  • Medical device adverse event reporting requirements in EU, Canada and US.
  • Medical device vigilance system during the post-production phase in EU.
  • Mandatory medical device problem reporting requirements in Canada.
  • Mandatory medical device reporting requirements in US.
  • Review of actual reporting forms in EU, Canada and US
  • Applicable and relevant guidance documents
  • Conclusion

Who Will Benefit:

  • Regulatory Affairs Managers, Directors and VPs
  • Clinical Affairs Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Compliance Managers and Directors
  • Sales and Marketing Managers, Directors, and VPs
  • Complaint Handling and Risk Management Managers and Directors
  • Site Managers, Directors, and Consultants
  • Senior and Executive Management
  • Compliance Officers and Legal Counsel
  • Business Development Managers, Directors, and VPs

Click Here to Continue Learning

Heart surgery survival chances ‘better in the afternoon’

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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.

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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.”

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

With Macy Foundation Grant, Drexel Teams with 12 Institutions to Enhance Professionalism in Medical Education

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The Josiah Macy Jr. Foundation has awarded a grant to Drexel University faculty to support the dissemination and enhancement of an online resource for teaching future health care providers about professionalism in medicine — including empathy, compassion, honesty, ethics and social justice.

Dennis Novack, MD, associate dean of medical education at the College of Medicine, was previously awarded a grant to create ProfessionalFormation.org (PFO), an online resource for professionalism learning, assessment, remediation and research in clinical education. With the support of the Macy Foundation, Novcack and Kymberlee Montgomery, DNP, chair of the Department of Advanced Practice Nursing in the College of Nursing and Health Professions, are working with a variety of institutions to disseminate and enhance this resource for over 30 health care education schools across the country.

“This generous grant will enable us to address the challenge of generating new educational resources for the entire health care education community. We will also publish educational research that contributes to a growing national understanding of the components of effective teaching and learning of professionalism and interprofessional care,” Novack said.

Teaming up with Drexel University are 12 institutions including: Alabama College of Osteopathic Medicine, Albert Einstein College of Medicine, Commonwealth Medical College, Duquesne University, Indiana University, Jefferson College, Ohio State University, Southeastern Louisiana University, Stony Brook, University of Pennsylvania, University of Texas – Rio Grande Valley and Western Michigan University School of Medicine. Each of these institutions is affiliating with colleges, such as nursing, pharmacy, physician assistants, dentistry and others for this unique collaboration.

“Leaders in health professions education have worried about the professional image of health care clinicians, and the public’s declining trust in health professionals. Managed care has grown, clinical care has become more fragmented, and there has been adverse publicity about errors in care,” Montgomery said. “A new paradigm for care demands commitments to professional values, and skills in working in teams. We are partnering with these institutions to enhance and expand their education in professionalism and interprofessional care. To practice together, it is essential to learn together.”

The American Board of Medical Specialties defines medical professionalism as a “belief system in which group members declare to each other and the public the shared competency standard and ethical values they promise to uphold in their work and what the public and individual patients can and should expect from medical professionals.” Central to those decelerations is a focus on an ethical value system, the knowledge and technical skills necessary for good medical practice and the interpersonal skills necessary for working with patients and colleagues.

Read More: http://snip.ly/4km9u#http://drexel.edu/now/archive/2017/September/Macy-Foundation-Grant-Professionalism/

Psychiatric care is postcode lottery, say medical experts

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists.

In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales.

London’s tally is more than double that of the east of England.

English health ministers said thousands of new posts were already planned.

The government in England recently announced there would be 570 extra consultant psychiatrists by 2020-21.

And the Welsh government said it was committed to improving mental health services in Wales.

But the Royal College of Psychiatrists said there were too few medical students specialising in psychiatry and not enough psychiatrists becoming consultants.

In England, in the past five years, it said there had been a 1.7% increase in psychiatry consultants compared with a 20.2% increase in other consultants across the NHS.

Areas such as London and the north-east of England have more than 11 psychiatrists per 100,000 people but the south-west has six and Yorkshire five.

‘Falling short’

Prof Wendy Burn, President of the Royal College of Psychiatrists, said: “People with a severe mental illness should expect to see a specialist consultant, just as you would for a severe physical illness.

“The huge variation in consultant psychiatrists across the country means reality is increasingly falling short of our expectations.

“As highly skilled medics, psychiatrists must be able to spot the nuance in symptoms, ask the right questions, and understand what the problem is.

 

Read More: http://snip.ly/u70ov#http://www.bbc.com/news/health-41201396