FWQRC, Quality Professionals

QUALITY PROFESSIONALS

Hi, Greetings from FWQRC……………..

Today’s topic is about how Quality professionals help organisations to deliver. We explain who they are and how they go about it

  • Everyone in an organisation is responsible for quality – from the CEO to the intern. But not everyone can be a quality expert. It’s important to have people who can provide the knowledge, tools and guidance to help everyone else play their part in pursuing excellence.These people are called quality professionals. Their job is to make sure organisations deliver.
  • Quality professionals come in many guises. Some are generalists, some are specialists. Many will have titles such as quality manager, quality engineer, quality director or assurance manager, while others deal with quality as part of a broader remit. Some are concerned with the delivery of products and services, while some are part of the leadership of an organisation. Some are employed in-house, while others work outside the organisations they deal with.
  • What unites quality professionals is their dedication to protecting and strengthening their organisations by making sure that stakeholders’ needs are met – and ideally, that their expectations are exceeded.

What quality professionals do

To put quality at the heart of their organisations, quality professionals focus on three specific areas, or competencies:

  • Strong governance: This starts with top management expressing a commitment to quality. Effective governance means making sure that the aims of management are crystal clear, that they reflect the requirements of stakeholders, and that the right people, policies and processes are in place to turn them into action.
  • Proper assurance: This ensures that the policies and priorities that have been decided on are being carried out properly, and that whatever is being produced – whether it’s a product, service, or project – is meeting stakeholders’ needs.
  • A culture of improvement: This means continually evaluating the organisation’s performance to improve efficiency, eliminate waste, reduce risk, respond to changes and create new opportunities.

The measure of a quality professional’s success is how well we

  • Protect reputation: avoiding the potentially catastrophic risks of getting things wrong
  • Enhance reputation: maximizing value for our customers and stakeholders
  • Improve profitability: eliminating unnecessary cost and waste and growing revenue
  • Drive change: contributing to the ongoing improvement of the organisation

Quality professionals are recognized by colleagues as

  • Agents for change: transforming processes, behaviour and culture
  • Guardians: protecting the business by identifying appropriate standards for business performance and assuring that they are met
  • Collaborators: working closely with leaders and managers
  • Leaders: creating, managing and improving the organisation’s business process systems
  • Progressive: understanding the realities of managing organisations in dynamic environments
  • Holistic: looking across business functions and hierarchies to advocate a broad process and customer-centric view of the organisation
  • Professional at FWQRC: qualified by professional institute (CQI), the CQI, and bound by a rigorous code of conduct.

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Regulatory Focus News Letter, Your Partner

National Drug Code(NDC)

Hi, Welcome to FWQRC Regulatory focus News Letter….

Here we are going to review the historic step taken by Trump Administration to lower U.S. prescription drug prices

Proposed rule could allow certain prescription drugs to be imported from Canada; draft guidance explains how manufacturers could import drugs, biological products originally intended for sale in another country

Today, President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
The NPRM issued today is the first step in implementing a provision of federal law that would allow for the importation of certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer. The draft guidance issued today describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign country is, in fact, an FDA-approved drug product, including that it is manufactured in accordance with the FDA-approved application.

“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Health and Human Services Secretary Alex Azar. “These are historic actions by HHS and the FDA, and they represent the bold nature of President Trump’s agenda for lowering drug costs. The President has recognized the opportunity to lower costs for American patients through safe importation, and we at HHS and FDA are delivering on that possibility through a safe, commonsense approach.”

The NPRM would allow states and certain other non-federal government entities to submit importation program proposals to the FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity. Referred to as Section 804 Importation Programs, these programs would be authorized by the FDA to manage the importation of certain prescription drugs that are approved in Canada and also meet the conditions in an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labeling prior to importation and undergo testing for authenticity, degradation, and to ensure that the drugs meet established specifications and standards. Notably, these programs would also have to demonstrate significant cost reductions to the American consumer.

“The FDA continues to assess and act on multiple opportunities to promote competition that can, in turn, help reduce drug prices and improve access to medicines for Americans,” said Assistant Secretary for Health Brett Giroir. “The proposed rule and draft guidance include procedures intended to protect the public’s health and safety. We look forward to receiving public comment on these draft policies, and we will take timely comments into account as we work to finalize the rule and guidance. Our ultimate goal is to provide a robust program that clearly lays out procedures to import drugs that could provide lower prices while also maintaining the high quality Americans expect.”

Of note, the draft guidance describes procedures drug manufacturers could follow to obtain an additional National Drug Code (NDC) for certain FDA-approved prescription drugs, including biological products, that were originally manufactured, and intended to be marketed, in a foreign country. The use of an additional NDC would allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require.

The draft guidance also recommends that the drug manufacturer include a statement on the product’s label and in the prescribing information to assist pharmacists to accurately identify, dispense and bill for these products. Prescription drugs, including biological products, imported under the pathway described in the draft guidance could be available to patients in a variety of settings, including hospitals, health care providers’ offices, or licensed U.S. pharmacies, and would include the FDA-approved labeling (including prescribing information).

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register

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