Technology Targeting Molecular Mechanisms

Bioelectronic medicine is now at a crossroads of the future of medical research where healthcare, technology and science join.

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In this blog Margot Puerta reports on the Bioelectronic Medicine: Technology Targeting Molecular Mechanisms symposium which took place in June. This three-day meeting had the aim of developing the field of bioelectronic medicine and brought together leading scientists and industry leaders from around the globe.

Technology is changing the world, including the world of pharmacological therapies that target molecular mechanisms. These therapies are expensive, difficult to administer, often toxic, and may be accompanied by lethal side effects. Through a convergence of molecular medicine, neuroscience and bioengineering, bioelectronic medicine seeks to develop cures that don’t require drugs or rely on them less heavily.

The second symposium, Bioelectronic Medicine: Technology Targeting Molecular Mechanisms was held June 12–14 in Saltsjöbaden, Sweden, presented by the Feinstein Institute for Medical Research, the Karolinska Institutet, and the Journal of Internal Medicine.

The field of bioelectronic medicine is aimed at interfacing electronics with nerves to specifically target the biological processes underlying disease. Bioelectronic medicine is now at a crossroads of the future of medical research where healthcare, technology and science join.

“With the discoveries that have been announced, and the research collaborations that are spanning the globe, the pace of bioelectronic medicine is accelerating,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institute and Editor in Chief of Bioelectronic Medicine. “As the global scientific home of bioelectronic medicine, it is important that the Feinstein Institute host a forum to discuss new findings and drive new discovery. We achieved that goal with this latest symposium.”

The three-day meeting brought together leading scientists and global experts from major institutions as well as industry leaders in biotechnology, including Galvani Bioelectronics, General Electric, GlaxoSmithKline, Medtronic and SetPoint Medical. The goal was to explore, define, and further develop the field of bioelectronic medicine. Session topics included: Defining Circuits, Clinical Updates, Molecular Targets, Neural Interfaces, Signal Processing, Disruptive Tools and Technology, and Accelerating Clinical Translation.

Presenters were encouraged to show their most recent advances. Many of the presentations included unpublished data, sparking thought-provoking discussion while contributing excitement about the latest developments in the field. At least one presenter was interrupted by spontaneous applause midway through the presentation. “I am inspired by the science, by the field advances, and by our collaborations in the short time since our groups hosted the last meeting in 2016,” said Peder Olofsson, MD, PhD, director of the Center for Bioelectronic Medicine at the Karolinska Institutet, and a chair of the symposia.

Read more at http://bit.ly/2KJTlu9

What does the medical device/biotechnology auditor look for and why?

How to maintain cleanliness in these areas and keep them presentable for the auditor.

Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.

Apart from going by these guidelines; the auditor also uses her intuition and observation gained from personal experiences to ensure that the facility she has visited is putting in place the right mechanisms to ensure what a state of control looks like. Given that a medical device audit can happen at just about any time; it is imperative for an organization in the medical device industry to be prepared for an audit any time, all the time.

What are the points that the manufacturer has to bear in mind to ensure compliance, so that the medical device audit goes on smoothly without events? What processes and methods should it follow to pass a medical device audit? These are critical questions that the manufacturer needs to have answers for.

Thorough learning on how to think like the auditor

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will equip participants with the knowledge needed to clear a medical device audit. José Mora, a Principal Consultant specializing in Manufacturing Engineering and Quality Systems, will be the speaker at this very important webinar. Over the more than 30 years that José worked in the medical device industry, he specialized in manufacturing, process development, tooling, and Quality Systems; he introduced process performance, problem solving, and Quality System methodologies.

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His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

You can gain the benefit of his experience by registering for this webinar at http://bit.ly/2laaQ7G

The mental checklist

The important learning of this webinar is that José will provide insight into the auditor’s way of thinking. He will explain the kinds of clues an auditor might use in determining what areas to focus on. Rather that offer a heads-up on the regulations and standards relating to medical device audits; José will give knowledge of the general mental checklist.

Adhering to this checklist, an intuitive one created more out of the expert’s knowledge and experience rather than one gleaned from textbooks, will go a long way in determining how well an audit goes. He will also explain what kind of culture and environment a medical device organization’s management has to inculcate and encourage, so that the medical device auditor gains a better than normal perception of the organization.

An eye on the visual clues

An experienced auditor who knows her job does not need to look too far or deep to discover anomalies. The checklist she has in her mind is enough for her to match the facility’s requirements with those in it. At this webinar, José will bring his years of experience in helping participants understand how to frame a mental checklist of their own, so that they map it with that of the auditor.

He will emphasize the importance of housekeeping, proper maintenance, orderliness, and following safety rules. He will also highlight the importance of objects that serve as visual indicators in the facility, and will show how to follow them. Generally, in most medical device facilities, utility rooms and custodial closets are dumping places for several items. An experienced auditor is aware that what a medical facility hides in these places are a greater indicator of the facility’s orderliness than what are kept in the clean and presentable areas. The expert at this webinar will show how to maintain cleanliness in these areas and keep them presentable for the auditor.

José will cover these areas at this webinar:

  • What the auditor is looking for and why
  • The first five minutes
  • Touring the plant and manufacturing area
  • Entering and touring the warehouse
  • Entering and touring a cleanroom
  • Entering and touring lab areas
  • Reviewing documents
  • Reviewing the quality system
  • Summary

This course offers immense benefit to those in charge of handling auditors. These include Managers, Supervisors, Directors, and Vice-Presidents.

Actions for Noncompliance of cGMPs in the Quality Control Laboratory

The inappropriate or incomplete implementation of cGMPs in the Quality Control labs is a major area for which the FDA takes penal actions against them.

Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.

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Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors and even behavior towards the FDA inspectors during inspections are some of the reasons for which laboratories get hauled up by the FDA. The inappropriate or incomplete implementation of cGMPs in the Quality Control labs is a major area for which the FDA takes penal actions against them.

Most common areas of noncompliance

These are some of the most common areas in which the FDA is likely to find issues relating to cGMPs in Quality Control laboratories:

  • Out of Specification lab results
  • Laboratory error- improper analysis method, use of incorrect standards, and/or miscalculation of data
  • Operator error or non-process error
  • Fault in the manufacturing process
  • Product failures
  • Laboratory documentation and records
  • Validation of methods
  • Equipment errors
  • Problems with raw materials
  • Lack of in-process controls and specifications
  • Management of the laboratory
  • Unexplained anomalies

Ways of avoiding penal actions

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From about the 1980’s, the FDA has been targeting Quality Control laboratories ever more stringently. The way of avoiding receipt of 483’s, which could escalate into a Warning Letter if it not addressed properly, is to be aware of all the ways by which to meet the FDA’s requirements of cGMPs in Quality Control laboratories. Some of the steps a QC laboratory needs to take to avoid FDA actions include:

  • Carefully reviewing and analyzing the regulations, inspectional guidance, 483 observations and Warning Letter and internal audit observations and deviations
  • Thoroughly reviewing laboratory practice and procedures
  • Gaining knowledge of the areas the investigators review and the type of observations that are made in other organizations and using this information to ensure that their laboratory operations are improved

Implementing actions based on these is at the root of its strategy for avoiding future observations of non-compliance and the issuance of 483’s from the FDA.

A valuable learning session on implementing these

How do laboratories do all these? How do they implement the correct cGMPs in their Quality Control laboratories, so that they meet the FDA’s compliance requirements? A webinar on this highly relevant and meaningful topic from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show how.

John Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System and Founder of The Lanese Group, which consults with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations; will be the speaker.

Please register for this highly valuable session by visiting and learn all that it takes to implement cGMPs in the Quality Control lab and avoid harsh penalties from the FDA, which could set your business back.

A thorough approach to imparting lessons on cGMPs

This is the approach that John will adapt for inculcating the lessons on cGMPs in the Quality Control laboratory:

He will apply one aspect of a proactive approach and review how this approach can be implemented for meeting regulatory requirements. He will then analyze 483 and Warning Letter observations to determine if similar observations that could serve as a benchmark to initiate further preventive actions could be made in the participants’ facility.

John will explain the non-conformances most often cited by the FDA, along with the relevant regulation. He will then show specific observations that relate to the laboratory cited in Warning Letters and FDA 483s. John will use these real life examples to show to participants the ways of analyzing what went wrong. He will explain the systems, procedures and records the laboratory should have in place that would prevent a similar observation. He will also familiarize the participants with several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and are being followed.

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Key personnel in laboratories, such as Quality Control Laboratory Managers, Quality Control Laboratory Supervisors, Quality Control Analysts, Quality Control Microbiologists, Quality Assurance Managers, and Quality Auditors will gain immense benefits by participating in this webinar. They will be able to critically evaluate key areas in the laboratory operations for compliance and identify areas for improvement after completion of this webinar.

John will cover the following areas at this webinar:

  • System Based Inspection Guidance
  • Laboratory Control System
  • Most common observations in the laboratory
  • 483 and Warning letter observations
  • Analysis of observations
  • Areas for preventive action.

Understanding steam sterilization microbiology

The methods of steam sterilization microbiology need to be understood thoroughly, since they need to comply with regulatory requirements.

Steam sterilization is an important means of killing microorganisms in microbiology. Sterilization is the method of removing all viable organisms from a source in a defined environment. Microorganisms are said to be dead when they are rendered ineffective by a decrease in their population in an environment. When they are unable to grow within their environment; they are considered dead. They don’t usually die the moment they are exposed to an agent that kills them.

Autoclaving is an important device used in steam sterilization microbiology. In addition to being used for sterilizing many devices such as surgical instruments, laboratory items and many more; an autoclave is also used in microbiology to sterilize microorganisms that cannot be killed by normal methods such as boiling and the use of strong detergents.

Autoclave qualification

The methods of steam sterilization microbiology need to be understood thoroughly, since they need to comply with regulatory requirements. An autoclave needs to be qualified for its performance, the basis for which is a proper grasp of stream sterilization microbiology.

Sterilization process parameters need to be laid out as a basis for conducting autoclave performance qualification studies. Exact standards of steam sterilization need to be met, whether it is to qualify a new autoclave installation or to continue maintenance of existing equipment.

A learning session on these methods

The ways of doing this will be the learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Danielle DeLucy, who owns ASA Training and Consulting, LLC, which provides pharmaceutical and biologics-based companies with training and quality systems assistance that helps them meet regulatory compliance. To understand the way by which your steam sterilization microbiology needs to meet regulatory compliance standards; please enroll for this webinar by visiting Steam Sterilization Microbiology

A full description of steam sterilization microbiology

Since successful autoclave Performance Qualification depends on a thorough grasp of steam sterilization microbiology; Danielle will describe the steam sterilization mechanism as it relates to bacterial cells and endospores. She will explain the process and key terminology, because understanding these fundamentals is critical to develop a successful autoclave sterilization process.

She will offer regulatory references requiring use of air removal verification tools, chemical indicators and biological indicators. She will also explain definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.

Quality Assurance Managers, Supervisors, Validation personnel and Sterility Assurance personnel will find this course useful. It is to meet the following objectives that this webinar is being organized:

o  Steam sterilization on a microbial level

o  Autoclave Performance Qualification expectations

o  Regulatory and GMP requirements for steam sterilization

o  Process verification tools for use in an autoclave Common questions, problems and cGMPs.

Danielle will cover the following areas at this webinar:

o  Autoclave Performance Qualification expectations

o  Regulatory and GMP requirements for steam sterilization

o  Validation tools for use in an autoclave

o  Common questions, problems and cGMPs.