How can a Culture of Quality and Compliance Impact your Company’s Success?

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality.

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If there is one attribute that sits at the very core of an organization, it has to be Quality. If Quality is this critical to organizations; then, what is Quality in the context of an organization?  If Philip Crosby defined Quality as conformance to requirements and Sam Walton considered it as being able to give the customers what they want; William A. Foster explained Quality in an organization in the following words: “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wise choice of many alternatives”.

Those in charge of Quality in organizations have to consider many questions relating to it. These are some of them: do we consider it an attribute or characteristic in relation to a certain standard or customer requirement? Is it all about achieving a state where our product is free from defects? Is it a system that we create for holding inspection standards or making the Quality System accountable to? Or is there something beyond all these?

Quality should become part of the organization’s culture

If there is one truly critical work that an organization has to carry out to become successful and to stay ahead; it is to imbibe Quality into its very core. Going beyond the semantics; Quality should become a way of life for the organization. it should become a philosophy, an inalienable part of its culture, and a habit. For organizations to meet and exceed customer expectations all the time and every time, Quality has to be implanted into the very essence of an organization.

Compliance4All, a well-known provider of professional trainings for the areas of regulatory compliance, explain all the elements of Quality at a webinar that it is organizing. Susanne Manz, a highly regarded leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma, and who brings extensive background in Quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the speaker at this webinar.

Please register for this webinar by visiting http://bit.ly/2Hs2QMI

Quality from all perspectives

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality. Among the important learning objectives of this session is to teach participants to identify the warning signals that indicate that there could be Quality issues within the organization and the risks the organization faces from Quality and compliance issues. Participants will understand the ways of changing their organizations from being reactive to becoming proactive. Participants will understand how a culture of Quality and compliance can impact their organization’s success, and will learn the ways of creating a culture of Quality and compliance at all levels in their organization.

Suzanne will cover the following areas at this webinar:

  • FDA and NB expectations for Quality Systems
  • Lessons Learned from 483s and warning letters
  • How culture can impact Quality and compliance risk
  • Management commitment and responsibility
  • Maturity Modeling
  • Key capabilities
  • Roles and responsibilities
  • Quality planning and strategy
  • Tools and techniques
  • Best Practices.

Where does GMP Training end and HR training begin?

HR could be in a predicament about what kind of training to impart to consultants.

That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).

This FDA section underlines the need for educational qualifications, training and experience to carry out their job functions, which cannot be carried out in the absence of these requirements. The consequences of having ill qualified and ill-equipped staff can be of a grave nature. This scenario calls for a thorough look at the way pharmaceutical companies select and train their staff engaged in their work that must incorporate Good Manufacturing Practices (GMPs), while also maintaining quality, which is of paramount importance in this industry, all within the ambit of the organizational culture.

Challenging questions relating to training requirements

Meeting the educational and training requirements for pharmaceutical professions in a GMP environment, while complying with the provisions of 21 CFR 211.25(a) can be quite a challenge for the pharmaceutical companies’ HR. HR training should align with the requirements set out by Quality Assurance. There must be consistency and alignment of the priorities and need of the stakeholders in these two crucial departments.

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HR could be in a predicament about what kind of training to impart to consultants, a practice that is quite prevalent in this industry. Are they to be trained the way regular staff is, or do they have a different set of training requirements? Another practice that abounds in this industry is transferred employees. What about the training for such employees?

Get to understand the elements of onboarding in a GMP environment

A webinar from MentorHealth, a leading provider of professional trainings for healthcare professionals, will be setting doubts relating to all these core areas at rest at a webinar that it is organizing. The speaker at this webinar is Michael Esposito, who has over 30 years of experience in the pharmaceutical industry, during which he has world in a variety of areas including packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations in many reputable companies such as Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division. Michael has more than 17 years’ experience in GMP training and document management.

Please visit http://bit.ly/2HJdw93 to enroll for this very useful session.

Familiarization with the onboarding strategy

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The essence of this webinar is familiarization with the onboarding strategy needed for professionals in the pharma industry. Michael will help participants understand how to put in place an onboarding strategy that combines the inputs of all the major stakeholders and put in place a consistent and comprehensible onboarding and training process that the organization can adapt for its employees.

Participants at this webinar will be able to define the onboarding process in the context of compliance. Michael will help them understand how to interact with HR to create a coordinated onboarding strategy. They will be able to implement a training program that takes into account the differences between the training requirements for full-time employees and contractors, and between new employees and employees transferring internally. They will also be able to prioritize training, so that they not only ensure compliance; they also reduce the learning curve for new or transferred employees.

This session is of value to professionals such as Managers with direct reports, HR professionals, and Quality Assurance and training departments. Michael will cover the following areas at this webinar:

  • FAQs for employee onboarding
  • Management’s expectations for new employees
  • HR onboarding
  • Quality’s role in the onboarding process
  • GMP training requirements
  • Handling full-time employees vs. contractors and other temporary personnel

Benchmarks for training and competency.

Safe and effective as a non PMA-subjected legally marketed device

Get down to doing the submission work and send the completed 510 (K) form to the FDA.

A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).

A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and design control requirements under the Quality System (QS) regulation. FDA provides guidance on how to meet the QS regulation requirements, under which all Class II and III devices and certain Class I devices have to be designed in conformance to 21 CFR 820.30 Design Controls.

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Step-by-step process for designing a bullet proof 510 (K)

Medical device companies which submit their premarket notification to the FDA for approval signal their intent to market their device. This submission has to be done at least 90 days before they register the product. Some logical and commonsensical steps have to be followed in designing a bullet proof 510 (K), meaning that the PMA is strong and not capable of being rejected by the FDA. Medical device manufacturers can follow these structured steps for designing a bullet proof 510 (K):

  1. Ensure, using the FDA classification database, that the product to be submitted for PMA is a medical device. This database is quite exhaustive, and has clear definitions and descriptions of the criteria that medical products have to meet if they have to be considered as medical devices
  2. In order to create a bullet proof 510 (K); the company has to also search and identify if similar products have already been approved by the FDA or others have filed for PMA for such a product with the FDA
  3. The medical device company has to next get a grasp of the guidances and standards that apply to the product that they are submitting for 510 (K). The FDA’s Product Classification Code is a good guide for this
  4. Get down to doing the submission work and send the completed 510 (K) form to the FDA
  5. Wait for the 90-day period that the FDA will take to review each submission
  6. Once the device has been cleared for submission by the FDA; the company has to start the registration process by paying the requisite fees after getting the unique 510 (K) number
  7. Appointing a US Agent, if the medical device manufacturer is from a country other than the US, is another important step for bullet proof 510 (K). The US agent takes care of the administrative work with the FDA.

FDA 21 CFR -Part 821 Medical Device Tracking Requirements

The device should be intended to be implanted in the human body for over a year.

Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately. This helps minimize damage, which could range from minor to fatal, depending on the kind of medical device in question.

21cfrPart821MedicalDeviceTrackingRequirementsThe 21 CFR -Part 821 medical device tracking requirements

The FDA’s 21 CFR -Part 821, which became effective in August 1993, is dedicated to medical device tracking requirements. This section requires manufacturers to maintain a system by which they can track the movement of either Class II or Class III devices once they have left the manufacturer’s facility. Tracking is considered the first step for further actions from the FDA, such as mandatory recalls.

Important factors for enforcing 21 CFR -Part 821 medical device tracking requirements 21 CFR -Part 821 medical device tracking requirements have guidelines on the steps that manufacturers must take in order to ensure that they are able to track medical devices after they have left the manufacturer’s facility. These are usually the factors:

  • Failure to track and recall the device should be quite likely to lead to adverse, serious health consequences;
  • The device should be intended to be implanted in the human body for over a year;
  • They should be life-sustaining or life-supporting devices that are put to use in a place outside of a device user facility.

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The Modernization ActThe Modernization Act, which became effective in February 1998, gives the FDA the discretion to decide which manufacturers of certain types of Class II or Class III devices should be part of its program for track their medical devices. By the terms of The Modernization Act, patients whose devices are tracked are not obliged to release details such as their social security number, name, address, or any other identifying information towards tracking.

Duration of tracking is left to the FDAPer 21 CFR -Part 821 medical device tracking requirements, the FDA will decide for how long a manufacturer’s device is being tracked. It will inform the manufacturer when it has decided to stop this activity.

How should manufacturers meet 21 CFR -Part 821 medical device tracking requirements?All manufacturers whose devices are being tracked must establish a written standard operating procedure (SOP). A clearly notified method for tracking the device throughout the distribution channel and a quality assurance program that is inclusive of audit procedures should be part of this undertaking.

PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001

We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001

PharmAbcine Inc., a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TTAC-0001 for “treatment of Glioblastoma Multiforme.”

“We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001 for GBM treatment since we have been preparing for clinical studies of TTAC-0001 plus KEYTRUDA® (pembrolizumab) combo therapy for recurrent GBM in addition to TTAC-0001 mono therapy for recurrent GBM progressed after bevacizumab treatment. It will accelerate the progress of TTAC-0001 to provide clinical benefit in the treatment of GBM,” said Dr. Jin-San Yoo, president and chief executive officer of PharmAbcine, Inc.

The FDA Office of Orphan Products Development grants Orphan Drug Designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including seven years of market exclusivity upon regulatory product approval, exemptions from certain FDA application fees, and tax credits for qualified clinical trials costs.

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About TTAC-0001 (=Tanibirumab)

PharmAbcine’s lead candidate TTAC-0001, an investigational therapy, is a highly selective and potent anti-VEGFR2 (KDR/flk-1) mAb in clinical development for rGBM indications. VEGFR2 is over-expressed in most malignant tumors, such as gastric, liver, non-small cell lung cancer (NSCLC), ovarian, brain, colorectal, and breast cancers and this signaling pathway is a key regulator for tumor angiogenesis.

Increased understanding of the role of VEGF/VEGFR2 in the tumor vessel formation, immune suppressive modulation of tumor micro environment (TME) and the function of the antagonist molecule to disorganized tumor vessel normalization, immune supportive modulation, and ultimately tumor vessel disruption, supports the rationale for evaluating TTAC-0001 in GBM, rGBM and Avastin® (bevacizumab) refractory GBM.

About PharmAbcine Inc.

PharmAbcine is a leading clinical stage biologics company that develops fully human therapeutic antibody (mAb) and next generation multispecific antibody therapeutics based on in-house developed novel platform, DIG-Body, PIG-Body and TIG-Body using innovative discovery technology and excellent human resources for the treatment of human diseases, such as cancer and inflammatory diseases.

PharmAbcine’s fully human antibody libraries and innovative selection system are our priceless proprietary assets. PharmAbcine provides antibody generation services by using antibody library and selection systems. PharmAbcine also provides co-development opportunities with novel antibodies.

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Under the collaboration with SAMSUNG MEDICAL CENTER, PharmAbcine has >300 patients derived cancer stem cell libraries and its animal model system for evaluating internal pipeline development.

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Why should organizations ensure FDA 21 CFR Part 11 Compliance?

Electronic signatures and records have to be authentic to the extent of being considered as being equivalent to actual, paper records.

The central reasoning behind FDA 21 CFR Part 11 Compliance requirements is that electronic signatures and records have to be authentic to the extent of being considered as being equivalent to actual, paper records.

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For this to happen, 21 CFR Part 11 sets out requirements that an organization has to meet to show compliance with these requirements. 21 CFR Part 11 lists the criteria that the FDA expects organizations to meet in order to have their electronic signatures and records be considered genuine.

Expectedly, given the serious nature of the electronic records and their signatures; FDA 21 CFR Part 11 Compliance sets out very stringent criteria for considering FDA-regulated industries electronic signatures and other records trustworthy.

The industries that require FDA 21 CFR Part 11 Compliance

These are some of the FDA-regulated industries to which 21 CFR Part 11 Compliance applies:

  • Biologics developers
  • Biotech companies
  • Medical device manufacturers
  • Drug makers
  • CROs

Any submissions made to the FDA in electronic format, such as a New Drug Application, are part of the documents to which FDA 21 CFR Part 11 Compliance applies.

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Things to be done to meet FDA 21 CFR Part 11 Compliance requirements

Specified FDA-regulated industries – with specific exceptions in these categories – need to put in place controls to ensure FDA 21 CFR Part 11 Compliance. Some of these controls include:

  • Audits
  • Audit trails
  • Documentation
  • System validations
  • Electronic signatures for software and systems that process electronic data that:
    • Are required to be maintained by the FDA Predicate Rules or
    • Are used to show compliance with a Predicate Rule.

What is the Predicate Rule?

Now, an understanding of the Predicate Rule: According to the FDA, any requirement stated in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11 constitutes a Predicate Rule.

Exemptions from FDA 21 CFR Part 11 Compliance

When it comes to exemptions, a strange logic is used: It is the format of filing, and not the type of industry, that determines if exemptions are to be allowed or not. If a submission made in electronic format requires FDA 21 CFR Part 11 Compliance; the compliance requirements do not apply to submissions made by the same industry in a paper format, and vice versa.

Another point of note is that record retention is not required for trace backs by food manufacturers.

Virtual healthcare has to be understood and used for what it can offer

Virtual healthcare can be seen as a natural extension of these uses of technology.

Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.

Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual technology has also been in widespread use in areas like education and for monitoring remote workers in many organizations. Virtual healthcare can be seen as a natural extension of these uses of technology.

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Understanding the dynamics of virtual healthcare

Healthcare analysts are quite upbeat about the growth prospects of virtual healthcare, making prognoses about its explosive potential growth, with estimates ranging from a size of well over $3 billion by 2022 to much rosier, nearly $14 billion for video consultation alone by 2018. While time will tell whether these forecasts will be fulfilled, we need to understand this tool and its prospects and pitfalls.

When adapting virtual healthcare, patients and healthcare providers are likely to use virtual healthcare in these ways:

Consultation

This should rank as the most important element of virtual healthcare. Virtual healthcare itself would come to be of no use if it did not offer the patient the opportunity to interact with the patient remotely. Patients are likely to use technologies in the form of tablets, smartphones and other personal devices to consult physicians.

virtualHealthcareConsultation is a very important component of virtual healthcare and it goes beyond just obtaining billing and other information that is usually a part of an Electronic Health Record (EHR). Virtual healthcare aids in direct, non-physical contact between the patient and the healthcare provider, which is what this medium primarily seeks to facilitate.

This feature is all the more useful in situations where the patient may not be in a condition to travel to the healthcare provider or where patients with long-term ailments need to be monitored on a regular basis without having to visit the hospital.

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Records

EHR could be another major component of virtual healthcare. Following the passage and implementation of Obamacare; the EHR has become a very important document for people seeking healthcare. Virtual healthcare can bring in a new dimension to EHR by enabling documentation and recording of important events in the physician-patient relationship.

Drawbacks of virtual healthcare

While there is no doubting the fact that virtual healthcare is set for major growth; it is important to understand its inadequacies. The most important disadvantage of virtual healthcare is that it is best suited only for noncritical healthcare situations. It may help patients with long term ailments, as mentioned above, but can help only when the patient has reached a stage where all treatments are done and only resuscitation or convalescence is needed. For a patient requiring immediate attention in an emergency, virtual healthcare is not likely to be very effective. Thus, a patient seeking medical information or advice for a viral infection is far more suited for virtual healthcare than a patient in need of CPR.

The uses to which virtual healthcare can be put are limited, at least at this stage of its development. When this technology advances enough to be able to offer healthcare in all situations and for all kinds of ailments; it will become a more effective medium. Till then, virtual healthcare has to be understood and used for what it can offer.