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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MITIGATING RISKS WITH BLACK CHAIN TECHNOLOGY

Hi, Greetings from FWQRC……….

This blog is related to how block chain contributes to drug supply management

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WHAT IS BLOCK CHAIN?

Block chain, or a distributed ledger, is a way of organisation information is a way that gives all appropriate parties access to the information they need and keeps that information secure from people who should not see it

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In terms of quality, block chains can ensure that every part of a supply chain can have assurance that the materials & products moving through it have reached a particular standard passed checks and compiled with necessary regulations

In its simple form,block chain is information that is shared across a group of computers so that if one person updates that information others are able to see it

HOW BLOCK CHAIN CONTRIBUTES TO DRUG SUPPLY-CHAIN MANAGEMENT

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Imagine a simple supply chain: Company A produces raw material;company B makes it into a product,while company C sells it. With block chain,company A can alert company B & company C of changes in supply chain-such as overproduction-that they can then use to moderate their manufacturing process. Company B could extend their working hours and sales strategy, while company C could plan a marketing campaign to move the extra product

Sharing decentralized information in this way means that business relationships will become much more flexible,benefiting the participants and requiring no outside help. This can be a highly effective means of self regulation

HOW BUSINESSES ARE USING BLOCK CHAIN IN THEIR SUPPLY CHAIN:

Global research firm, Gartner, predicts that by 2023,some 30% of manaufacturing complanies with revenue of more than $5bn will be using block chain to drive down costs and improve tracebility and transperancy

Block chain as a strategy will force companies to look beyond the boundaries of their own firm & establish shared process and consensus mechanisms with their supply chain partners

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CHALLENGES OF THE MODEL

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• The benefits are great,but they may come at a cost
• Block chain represents a challenge for businesses “Companies that have an ageing information technology infrastructure will struggle to interact effectively with digitally native companies
• Tech companies have a responsibility to make the user experience as easy & seamless as possible for everyone in the supply chain

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Cosmetic Registration Reports

Hi, Welcome to FWQRC Regulatory Focus News Letter

About Blog FWQRC Regulatory focus pharma news, views and analysis of healthcare in a rapidly changing world. Not only do we keep you connected with the latest trends in pharma, we can also help you develop and bring to life your own thoughts, ideas and inspirations to enable you and your business to become key pharma influencers

The information in the tables below is a monthly report of activity in FDA’s Voluntary Cosmetic Registration Program (VCRP)

VCRP Monthly Status Report

Because the law does not require cosmetic firms to register their establishments or file their product formulations with FDA, participation in this program is voluntary. For this reason, the information below does not indicate the total number of companies manufacturing or marketing cosmetics in this country, or all cosmetic products on the market.

Activity for December 2019

• Number of online accounts activated this month: 103
• Number of products filed this month: 593
• Total activity since the launch of the new online system, September 20, 2018
• Number of active online accounts: 2,816
• Number of active cosmetic establishment registrations: 1,395
• Number of labelers that have filed product formulations*: 650
• Number of filed products: 8,333
• Number of product formulations discontinued**: 373
• Number of product formulations rejected***: 958
• Total activity since the VCRP was established, in 1972
• Number of active cosmetic establishment registrations: 4,392
• Number of labelers that have filed product formulations*: 3,071
• Number of active products on file: 68,838
• Number of product formulations discontinued**: 82,094
• Number of product formulations rejected***: 5,101

FWQRC™ intended to provide a decision pathway for drug & medical devices manufacturers in their first steps towards implementation of eCTD publishing and submission

Hi, Welcome to FWQRC™ Regulatory Focus News Letter

About Blog: FWQRC™ Regulatory focus pharma news, views and analysis of healthcare in a rapidly changing world. Not only do we keep you connected with the latest trends in pharma, we can also help you develop and bring to life your own thoughts, ideas and inspirations to enable you and your business to become key pharma influences

Many of us aware that eCTD is mandatory for DMF submissions from Jan 2020.

• At the beginning of the decision process it is very important to make an evaluation of the current submission processes (“where are we”) in comparison with the eCTD requirements (“where do we need to be”).
• The conclusions drawn from this analysis, together with a careful evaluation of the boundary conditions within the company are the basis for the definition of the User Requirements Specifications (URS). 
• In the URS all the needs and boundaries of the expected processes are described and this information is used to find the optimal solution.Three possible solutions are described in detail, with their related advantages and disadvantages

1. In-house software,
2. Software as a Service (SaaS) and
3. Outsourcing  

• The last step of the process is the implementation of the chosen solution.
• It has to be considered whether a consultant should help with the creation of this URS document. Especially for the generation of the new processes the experience of a consultant can be helpfulThe URS is part of the official validation documentation according to GAMP and should be established for any new system

• Selection of solution

• Once the URS has been finalised, the most suitable solution has to be found.  For this analysis the URS requirements should be classified in some way, e.g. “crucial” and “nice to have”.

• The three possible solutions (In-house Software, Software as a Service and Outsourcing) are described in detail in the following sections.  Table 1 compares the most relevant characteristics of the 3 solutions, Table 2: Running an eCTD software system in-house: advantages and disadvantages and Table 3: Host system option: advantages and disadvantages

Table 1: Comparison of the 3 solutions

Item	In-House software	Software as a Service	Outsourcing
Freedom of configuration	High	limited	No
Responsibility for update and Maintenance	High	No	No
IT support in-house needed	Yes	No	No
Link to other IT systems in-house possible	Yes	No	No
Initial costs	High	Low	No
Ongoing costs	In-house	Yes	Yes
Lead time	Long	Medium	Short
Scalability	Depends on set-up	Easy	Easy
Need of resources and competence for use of eCTD software	Yes	Yes	No
confidentiality / data security issues	No	Yes	Yes

Table 2: Running an eCTD software system in-house: advantages and disadvantages

Advantages	Disadvantages
Full freedom for configuration	High initial costs for setting up the system
Free choice of hardware and software components	Relatively long lead time needed to set up the system
The software is part of the company-owned software and fits into the IT concept of the company	Full responsibility for update and maintenance
Everything stays in house (no data-transfer via internet / confidentiality etc.)	Personnel for technical set-up and maintenance must be available.
Link-up to other IT-systems possible (e.g. SAP)
Maintenance costs stay in-house
On-going costs are lower compared to the host software or outsourcing options

Table 3: Host system option: advantages and disadvantages

Advantages	Disadvantages
Speed: time from the decision to a pilot eCTD is often shorter compared to the in-house software solution	Dependency on an external partner which increases if also the DMS shall be hosted
Lower cost for initial implementation as there is no or a smaller initial investment (e.g. initial set-up, user and software licenses, maintenance)	Data transfer via internet (confidentiality, upload / down load capacity)
Scalable: ability to scale as business needs change	Data hosted at an external company (confidentiality)
No on-going system maintenance	Limited freedom for software configuration
	On-going costs for renting the system/service

Table 4: Outsourcing option: advantages and disadvantages

Advantages	Disadvantages
Speed: time from the decision to a pilot eCTD is very short	Dependency on an external partner for each project and throughout the life cycle of a submission
No initial investment and no reoccurring costs for system maintenance and technical support	On-going costs for each service during the whole lifecycle of a product/submission (initial submission(s), variations etc.)
No direct costs for software, licenses, hardware, system validation and maintenance, training	Data transfer (confidentiality, upload / down load capacity)
No need to establish, maintain technical knowledge in building and publishing eCTDs, no need for respective in-house resources (eCTD builder/publisher)	Data hosted at an external company (confidentiality)
Scalable: ability to scale as business needs change
Can also substantially-reduce risk of failed initial submissions

• There are 4 main scenarios that can drive the decision for outsourcing

1. there is no in-house software available to build / publish eCTDs or
2. the in-house capacities are too little
3. to gain experience for the creation of eCTD ready documents and eCTD submissions in-house
4. the number of eCTD submissions is too small, seldom use of the system

• Conclusion: The option with the lowest impact on processes and systems in a company is outsourcing. There are various different extents of outsourcing. Common to all is that the external partner will provide the necessary infrastructure / software as well as the personnel to prepare the eCTD.

Stay in connected with FWQRC™ for implementation of eCTD publishing & submission