This document discusses five steps for ensuring regulatory compliance when outsourcing business functions in highly regulated industries. It begins by explaining how strict regulations in industries like pharmaceuticals and food production present challenges for outsourcing. It then provides five steps companies can take to help outsourcing providers maintain compliance: 1) establish regulatory frameworks, 2) develop well-trained teams, 3) deploy knowledge retention strategies, 4) create a compliant workplace culture, and 5) maintain accountable processes. The document concludes with a case study of how one company improved regulatory compliance and reduced staff turnover by outsourcing certain functions.
Driving Performance Excellence in the Regulatory Affairs Function at Medical ...Best Practices
Optimizing the resource and staffing levels at medical device companies enables Regulatory Affairs leaders to prioritize roles and responsibilities, thereby driving organizational growth.
Research & Consulting leader, Best Practices, LLC engaged Regulatory Affairs leaders at 32 leading medical device companies through a benchmarking survey to capture insights regarding current and future trends shaping the Regulatory Affairs function. This study delivers benchmarks around the critical drivers of regulatory performance excellence at medical device companies.
Download Full Report: http://bit.ly/2asHvQh
Regulatory Affairs Outsourcing Considerations and ModelsPaul Kuiken
I present a number of issues which are being considered by all organisations in the healthcare, pharmaceutical, biotechnology, and clinical sectors. I presented this to an audience at an outsourcing summit and have tailored this to a more general audience.
I am happy to receive your comments and provide your insights to whether you agree or not with my points or to hear from you regarding your experiences of outsourcing in whatever sector you are interested in.
Enterprise Labeling for the Medical Device IndustryLoftware
IT’S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL
DEVICE LABELING. For medical device manufacturers, labeling is growing in importance, and there are a number of reasons why.
Enterprise Labeling for the Pharmaceutical IndustryLoftware
For the pharmaceutical industry, the focus is on patient safety and improved patient outcomes. It’s also on driving greater efficiencies, cost reductions, and collaboration with contract manufacturers throughout the supply chain. In this environment, labeling is growing in importance, and there are a number of reasons why.
Driving Performance Excellence in the Regulatory Affairs Function at Medical ...Best Practices
Optimizing the resource and staffing levels at medical device companies enables Regulatory Affairs leaders to prioritize roles and responsibilities, thereby driving organizational growth.
Research & Consulting leader, Best Practices, LLC engaged Regulatory Affairs leaders at 32 leading medical device companies through a benchmarking survey to capture insights regarding current and future trends shaping the Regulatory Affairs function. This study delivers benchmarks around the critical drivers of regulatory performance excellence at medical device companies.
Download Full Report: http://bit.ly/2asHvQh
Regulatory Affairs Outsourcing Considerations and ModelsPaul Kuiken
I present a number of issues which are being considered by all organisations in the healthcare, pharmaceutical, biotechnology, and clinical sectors. I presented this to an audience at an outsourcing summit and have tailored this to a more general audience.
I am happy to receive your comments and provide your insights to whether you agree or not with my points or to hear from you regarding your experiences of outsourcing in whatever sector you are interested in.
Enterprise Labeling for the Medical Device IndustryLoftware
IT’S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL
DEVICE LABELING. For medical device manufacturers, labeling is growing in importance, and there are a number of reasons why.
Enterprise Labeling for the Pharmaceutical IndustryLoftware
For the pharmaceutical industry, the focus is on patient safety and improved patient outcomes. It’s also on driving greater efficiencies, cost reductions, and collaboration with contract manufacturers throughout the supply chain. In this environment, labeling is growing in importance, and there are a number of reasons why.
BatchPro, the exclusive ERP system by eresource it is the most advanced integrated Pharmaceutical ERP solution.
* Make pharmaceutical business more quality-oriented with eresource BatchPro
* Bpro system readies companies to face business challenges
* Flexible, configurable, affordable and reliable ERP system
* Implementation process includes thorough user training
Click here for Free Online Demo of our Product
https://www.eresourceerp.com/erp-for-pharmaceutical/
In this ptresentation i have talked about corporate compliance program Specially Endo Pharmaceuticals corporate compliance program. Here is discussed about Some external government requirements related to compliance, Elements of an Effective Compliance Program, Corporate Compliance & Business Practices, Endo's Culture of Compliance, Leadership responsibilities, Code of Conduct, Reporting a Concern, Findings from corporate compliance. We have also recommended for overcoming some drawbacks related to corporate compliance to do so they will have to make the corporate compliance more effective & more motivational & more efficient. The study is performed based on the information extracted from different sources collected by using a specific methodology. This report is analytical in nature. To prepare the report on corporate compliance policy and procedure of Endo Pharmaceuticals. The information has been collected from secondary sources.
Benchmarking Quality: How Medical Device and Diagnostics Companies Manage Cos...Best Practices
Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle, from R&D to post-market activity. Facing tight budgets and escalating regulations, quality leaders are preparing to shift resources, automate and outsource activities, develop and retain key talent, and build business plans that justify their budgets.
This Best Practices, LLC, report delivers comprehensive survey benchmarks on how medical device companies are defining and allocating Quality spend, identifying factors that impact spending levels, and investing in future mission-critical Quality activities.
Quality leaders can use the evidence-based metrics and insights for Quality spending, staffing, change request levels, outsourcing, software quality, inspections, lab testing, complaint management, trend insights and more.
Product Complaints: Complaint Handling from Intake to ClosureGRCTS
Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.
In the context of globalisation and international competition, many companies source labour-intensive goods from developing and newly industrialised countries. However, working conditions in these countries often do not comply with basic labour standards, such as those established by the International Labour Organization (ILO). To address this issue, many companies and associations have created individual codes of conduct and monitoring systems.
SA8000 and BSCI are some of the monitoring systems. The audit process helps to identify the better suppliers who can take on more business as non-conforming suppliers drop out of the supply chain.
What can we expect in the future? (tomorrow), Paul Phyall, Senior Vice President LRQA Asia. Presentation on the future of management system standards and what organisations expect and what auditors must deliver.
REGULATORY LABELING AND THE INDUSTRY CHALLENGESFreyr Solutions
To comply with time-critical labeling mandates, organizations face many procedural challenges while creating, tracking and managing various aspects of drug labeling lifecycle.
In that regard, before even searching for a right labeling solution.....
The new draft of ISO14001 makes some fundamental changes to the current standard. This presentation explores the key strategic changes and legal compliance aspects.
Staying in compliance with rules and regulations may be a daunting task for organisations of all sizes. Noncompliance can have serious consequences, ranging from large penalties and court battles to reputational damage. This is where the worth of a "Compliance Audit Service" becomes clear. A Compliance Audit Service is a third-party supplier that supports organisations in ensuring compliance with all necessary legislation and norms. Companies can find piece of mind by employing the services of a Compliance Audit Service, knowing that they are meeting all legal standards and avoiding any penalties and legal entanglements. In this blog post, we will look at why a reliable Compliance Audit Service provider is essential in today's corporate scene. We will also highlight the distinguishing characteristics that set a supplier apart from the competitors. So, if you want to keep ahead of the curve and secure your company's continued compliance, check out the parts below!
BatchPro, the exclusive ERP system by eresource it is the most advanced integrated Pharmaceutical ERP solution.
* Make pharmaceutical business more quality-oriented with eresource BatchPro
* Bpro system readies companies to face business challenges
* Flexible, configurable, affordable and reliable ERP system
* Implementation process includes thorough user training
Click here for Free Online Demo of our Product
https://www.eresourceerp.com/erp-for-pharmaceutical/
In this ptresentation i have talked about corporate compliance program Specially Endo Pharmaceuticals corporate compliance program. Here is discussed about Some external government requirements related to compliance, Elements of an Effective Compliance Program, Corporate Compliance & Business Practices, Endo's Culture of Compliance, Leadership responsibilities, Code of Conduct, Reporting a Concern, Findings from corporate compliance. We have also recommended for overcoming some drawbacks related to corporate compliance to do so they will have to make the corporate compliance more effective & more motivational & more efficient. The study is performed based on the information extracted from different sources collected by using a specific methodology. This report is analytical in nature. To prepare the report on corporate compliance policy and procedure of Endo Pharmaceuticals. The information has been collected from secondary sources.
Benchmarking Quality: How Medical Device and Diagnostics Companies Manage Cos...Best Practices
Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle, from R&D to post-market activity. Facing tight budgets and escalating regulations, quality leaders are preparing to shift resources, automate and outsource activities, develop and retain key talent, and build business plans that justify their budgets.
This Best Practices, LLC, report delivers comprehensive survey benchmarks on how medical device companies are defining and allocating Quality spend, identifying factors that impact spending levels, and investing in future mission-critical Quality activities.
Quality leaders can use the evidence-based metrics and insights for Quality spending, staffing, change request levels, outsourcing, software quality, inspections, lab testing, complaint management, trend insights and more.
Product Complaints: Complaint Handling from Intake to ClosureGRCTS
Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.
In the context of globalisation and international competition, many companies source labour-intensive goods from developing and newly industrialised countries. However, working conditions in these countries often do not comply with basic labour standards, such as those established by the International Labour Organization (ILO). To address this issue, many companies and associations have created individual codes of conduct and monitoring systems.
SA8000 and BSCI are some of the monitoring systems. The audit process helps to identify the better suppliers who can take on more business as non-conforming suppliers drop out of the supply chain.
What can we expect in the future? (tomorrow), Paul Phyall, Senior Vice President LRQA Asia. Presentation on the future of management system standards and what organisations expect and what auditors must deliver.
REGULATORY LABELING AND THE INDUSTRY CHALLENGESFreyr Solutions
To comply with time-critical labeling mandates, organizations face many procedural challenges while creating, tracking and managing various aspects of drug labeling lifecycle.
In that regard, before even searching for a right labeling solution.....
The new draft of ISO14001 makes some fundamental changes to the current standard. This presentation explores the key strategic changes and legal compliance aspects.
Staying in compliance with rules and regulations may be a daunting task for organisations of all sizes. Noncompliance can have serious consequences, ranging from large penalties and court battles to reputational damage. This is where the worth of a "Compliance Audit Service" becomes clear. A Compliance Audit Service is a third-party supplier that supports organisations in ensuring compliance with all necessary legislation and norms. Companies can find piece of mind by employing the services of a Compliance Audit Service, knowing that they are meeting all legal standards and avoiding any penalties and legal entanglements. In this blog post, we will look at why a reliable Compliance Audit Service provider is essential in today's corporate scene. We will also highlight the distinguishing characteristics that set a supplier apart from the competitors. So, if you want to keep ahead of the curve and secure your company's continued compliance, check out the parts below!
Safety and Regulatory Solutions to Address the Needs of Small and Medium Biop...Covance
Clinical trials are typically outsourced to full-service clinical research organisations (CROs) and many SMEs select them based on a CRO's ability to recruit patients in certain geographies and therapeutic areas. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
WeSchool Offers Online MBA Program in Operations Mgmt. Production planning, project management & world-class manufacturing are among the critical concepts.
In their efforts to decrease costs, improve customer loyalty and extend brand reputation, organizations need a holistic, long-term view of enterprise quality management systems.
How Can CSOs Transform Environmental Compliance into Market Wins.pdfCarbon Minus
Discover how Chief Sustainability Officers (CSOs) can leverage environmental compliance as a catalyst for market success. Explore actionable strategies and insights to navigate regulatory landscapes, implement sustainable practices, and transform compliance burdens into opportunities for innovation and differentiation. Learn how embracing environmental responsibility can not only enhance brand reputation but also drive profitability and resilience in today's competitive marketplace.
Download now to unlock the potential of environmental compliance as a strategic asset for your organization's growth and sustainability journey.
India is the new start-up nation! With third highest start-ups launched in the world after US and UK in the year 2015. To build the investors’ confidence and brand reputation, to drive the top line growth and protect the bottom line, it’s imperative for any start-up to be ready! As startup our plan should focus all three aspects of a business i.e. Commercial, Financial and Compliance.
Lecture 17 sas framework internal control - james a. hall book chapter 3Habib Ullah Qamar
SAS Framework,Chapter 3 Of Accounting Information System. Frauds ,ethics and Internal Control, Levels of SAS-78/COSO Framework. The Control Environment, Risk Assessment, Monitoring, Supervision and in the end Control Acvities
NetZealous LLC: Regulatory and Compliance Trainings –a great opportunity to s...NetZealous LLC
Regulatory compliance is a vital requirement in several industries. Its importance in the life sciences is all the more pronounced, given the importance of human lives, with which the life sciences deal. Regulatory compliance is the act of being in accordance with set standards and specifications of the products or services that come from an industry. Regulatory guidelines and requirements are set out by regulatory bodies in respective industries. These regulations are arrived at after painstaking research.
How an Organization Can Elevate Compliance Standards360factors
A properly designed and effectively executed compliance program is critical for enhancing and validating company performance and reducing compliance risk. However, the efficacy of a compliance program depends on whether it is a paper program or is integrated within the company and used almost daily.
To elevate compliance standards, organizations can follow the below-mentioned practices:
• Understand the Requirements
• Identify and Assess Compliance Program
• Create Transparency
• Ensure Operational Compliance
• Resolve Problems and Issues
For more details: https://bit.ly/3REefMr
Ahead of the marcus evans National Healthcare CFO Summit Fall 2019, read here an interview with Joni Noel discussing how healthcare CFOs can ensure their health system is compliant with the new lease accounting standard under ASC 842 or GASB 87
Pharmacovigilance Smart Sourcing Strategy: Vendor Selection for Safety & Risk...Covance
Strategic planning, sourcing and implementation of safety and risk management operations are complex activities that involve a multitude of factors. Due to the maturity of the outsourcing industry, compliant, quality and efficient safety operations are basic expectations now for the outsourcing of pharmacovigilance (PV) activities. This trend has enabled sponsors to focus their in-house resources on the strategic elements of safety and risk management while leveraging the service provider's capabilities.
Operational resilience is that side of risk, personnel and business continuity that rallies a firm to reduce disruptions in service when things go wrong.
Discover the Financial Conduct Authoritys (FCA) take on the subject.
Have an internal control expert reduce the risk CflCoaching
Rather an expert will help design controls that would be contributing towards an effective risk management.
Your organization can greatly benefit with an internal control expert
As a pioneer in the staffing industry, and in the study of workforce preferences, Kelly takes a high-level look at collaboration as it pertains to the global worker today. In addition to analyzing worker preferences and psychographic insights based on survey data from the 2015 and 2014 Kelly Global Workforce Index™ (KGWI), this report pulls insights from Kelly Free Agent research (2015) survey data and other research sources. Unless otherwise noted, all statistics come from recent Kelly workforce research data.
Maßnahmen gegen den Fachkräftemangel in Europa in den Bereichen Mathematik, Informatik, Naturwissenschaft und Technik: Warum eine Strategie der Inklusion entscheidend ist.
Wenn wir den massiven Fachkräftemangel in den MINT-Berufen (Mathematik, Informatik, Naturwissenschaft und Technik) in Europa lindern wollen, müssen wir schleunigst damit beginnen, mehr Frauen einzustellen. Und wir müssen dabei an einem Strang ziehen. Zur Optimierung des MINT-Talentepools durch größere Diversität bedarf es jedoch mehr als nur ein wenig zusätzlicher Mühe bei der Personalanwerbung. Vor allem gilt es, ein Klima der Inklusion zu schaffen, das die Einstellung und Bindung von Frauen in der MINT-Branche begünstigt. Gleichzeitig müssen Unternehmen die Beseitigung von Vorurteilen und Barrieren zur Priorität erheben und zur Chefsache erklären; Führungskräfte müssen aktive Unterstützung leisten und institutionelle Verantwortung übernehmen. Des Weiteren ist es von wesentlicher Bedeutung, Frauen in diesen Berufen ein besseres Mentoring zu bieten und die Diversität weiter zu erhöhen. Denn es steht eine ganze Menge auf dem Spiel – und das betrifft nicht nur Ihr Unternehmen, sondern die Zukunft der Branche in ganz Europa.
Als Pionier auf dem Gebiet der Personaldienstleistungen und der Erforschung von Arbeitnehmervorlieben bietet Kelly Services eine umfassende Analyse, die verdeutlicht, weshalb es so wichtig ist, gegen die Unterrepräsentation von Frauen in Europas MINT-Branche anzugehen. Dabei untersuchen wir auch, welche Faktoren Unternehmen berücksichtigen müssen, um diese Spezialistinnen langfristig zu binden.
Neben der Analyse von Arbeitnehmervorlieben und psychographischen Einblicken auf Grundlage der Umfrageergebnisse aus dem Kelly Global Workforce Index von 2014 und 2015 werden in diesem Bericht auch Erkenntnisse aus der Kelly Free Agent Research-Studie von 2015 und sekundären Quellen berücksichtigt. Sofern nicht anders angegeben, stammen alle Statistiken aus aktuellen Arbeitsmarktstudien von Kelly.
The Kelly Global Workforce Index (KGWI) is an annual global survey that is the largest study of its kind. In 2015, Kelly collected feedback from 164,000 workers across 28 countries across the Americas, EMEA, and APAC regions and a multitude of industries and occupations.
This study is taking a high level look at:
- Work-Life Design as it pertains to the global worker today.
- Women in STEM Talent Gap - a study that at the gap of women talent in STEM – Science, Technology, Engineering and Math – fields.
- Career Management – specifically the emerging trend of do-it-yourself (“DIY”) career development – as it pertains to the global worker seeking to be as resilient as possible in today’s uncertain environment
- Collaborative Work Environment as it pertains to the global worker today.
Here is our second global report on the topic Women in STEM.
Want to move your career forward? Looking to build your leadership skills while helping others learn, grow, and improve their skills? Seeking someone who can guide you in achieving these goals?
You can accomplish this through a mentoring partnership. Learn more about the PMISSC Mentoring Program, where you’ll discover the incredible benefits of becoming a mentor or mentee. This program is designed to foster professional growth, enhance skills, and build a strong network within the project management community. Whether you're looking to share your expertise or seeking guidance to advance your career, the PMI Mentoring Program offers valuable opportunities for personal and professional development.
Watch this to learn:
* Overview of the PMISSC Mentoring Program: Mission, vision, and objectives.
* Benefits for Volunteer Mentors: Professional development, networking, personal satisfaction, and recognition.
* Advantages for Mentees: Career advancement, skill development, networking, and confidence building.
* Program Structure and Expectations: Mentor-mentee matching process, program phases, and time commitment.
* Success Stories and Testimonials: Inspiring examples from past participants.
* How to Get Involved: Steps to participate and resources available for support throughout the program.
Learn how you can make a difference in the project management community and take the next step in your professional journey.
About Hector Del Castillo
Hector is VP of Professional Development at the PMI Silver Spring Chapter, and CEO of Bold PM. He's a mid-market growth product executive and changemaker. He works with mid-market product-driven software executives to solve their biggest growth problems. He scales product growth, optimizes ops and builds loyal customers. He has reduced customer churn 33%, and boosted sales 47% for clients. He makes a significant impact by building and launching world-changing AI-powered products. If you're looking for an engaging and inspiring speaker to spark creativity and innovation within your organization, set up an appointment to discuss your specific needs and identify a suitable topic to inspire your audience at your next corporate conference, symposium, executive summit, or planning retreat.
About PMI Silver Spring Chapter
We are a branch of the Project Management Institute. We offer a platform for project management professionals in Silver Spring, MD, and the DC/Baltimore metro area. Monthly meetings facilitate networking, knowledge sharing, and professional development. For event details, visit pmissc.org.
New Explore Careers and College Majors 2024.pdfDr. Mary Askew
Explore Careers and College Majors is a new online, interactive, self-guided career, major and college planning system.
The career system works on all devices!
For more Information, go to https://bit.ly/3SW5w8W
The Impact of Artificial Intelligence on Modern Society.pdfssuser3e63fc
Just a game Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?
NIDM (National Institute Of Digital Marketing) Bangalore Is One Of The Leading & best Digital Marketing Institute In Bangalore, India And We Have Brand Value For The Quality Of Education Which We Provide.
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Jill Pizzola's Tenure as Senior Talent Acquisition Partner at THOMSON REUTERS...dsnow9802
Jill Pizzola's tenure as Senior Talent Acquisition Partner at THOMSON REUTERS in Marlton, New Jersey, from 2018 to 2023, was marked by innovation and excellence.
Exploring Career Paths in Cybersecurity for Technical CommunicatorsBen Woelk, CISSP, CPTC
Brief overview of career options in cybersecurity for technical communicators. Includes discussion of my career path, certification options, NICE and NIST resources.
3. It’s no secret that outsourcing has changed the way many
organizations work. Over the next two years, 72 percent of
companies worldwide plan to increase their reliance on outsourcing
to some degree. Already, 96 percent are outsourcing some element
of their back-office and other basic operations.1
However, in rigorously regulated environments the benefits of outsourcing becomes
less clear. In highly regulated industries such as pharmaceuticals, medical devices
and food production, failure to comply with strict procedural standards can result in
substantial penalties.
Such pressures encourage organizations to maintain careful control over their
compliance, building regulatory considerations into business processes, staff training
and documentation procedures, so everything is as it should be in case of audit. These
measures are often intricate, so it’s understandable for these businesses to be reluctant
in entrusting them to a third party.
Despite compliance risk, growing competition and constantly evolving markets
mean outsourcing still holds substantial appeal for businesses that operate in highly
regulated industries.
INTRODUCTION /03
Constantly evolving
markets mean
outsourcing still holds
substantial appeal
for businesses that
operate in highly
regulated industries.
1
David Brown, Phil Fersht, “Executive report: The State of Services & Outsourcing in 2014,” KPMG, www.kpmg-institutes.com/content/
dam/kpmg/sharedservicesoutsourcinginstitute/pdf/2014/state-of-outsourcing-2014-exec-findings-hfs.pdf.
4. This presents companies with a difficult decision: keep core processes in-house and risk
being outpaced by more resourceful competitors, or trust third party outsourcers to
take ownership over regulatory compliance.
Regulation adds complexity to the outsourcing process. But businesses can mitigate
any uncertainty by ensuring their providers build compliance into the processes and
workforces that support outsourced projects. In this paper, we present five factors
you can put in place to help you make sure your outsourced business functions meet
regulatory expectations in the long term.
/04INTRODUCTION
Businesses can mitigate
any uncertainty by
ensuring their providers
build compliance into
the processes and
workforces that support
outsourced projects.
6. In highly controlled environments, the cost associated with
regulatory audits, fines, lost customers and even temporary closure
can negate the benefits of outsourcing in the first place.
Most industries must comply with some kind of regulation. In the finance industry,
accountability and transparency are increasingly regulated to protect consumers.
Construction businesses face requirements relating to building standards, competing
land usage and occupational health and safety. According to the CDRH, the U.S. is the
world’s leader in regulatory science, medical device innovation and manufacturing, and
radiation-emitting product safety.
Some industries are more rigorously regulated than others. For example, the US
Food and Drug Administration (FDA) and the US Department of Agriculture (USDA),
respectively require pharmaceutical and food production companies to follow strict
anti–cross-contamination protocols when cleaning machinery used to process different
products. In addition to similar cleanliness standards, the FDA and DEA require
businesses in the pharmaceuticals industry to assign a serial number to every bottle, case
and pallet of certain products, to enable tracking of counterfeit or controlled substances.
Furthermore, the pharmaceuticals industry is also subject to Free Trade Zone (FTZ)
requirements as it relates to logistics and supply chain components.
/06CAN YOU AFFORD TO OUTSOURCE HIGHLY REGULATED PROCESSES?
Some industries
are more rigorously
regulated than
others.
7. Fear of regulatory fall out
Failure to comply with these and other regulations exposes businesses to a range of
complicating factors. Regulatory scrutiny can result in fines and restrictions on what a
business is legally permitted to produce. Regulators can even force a business to halt
non-compliant departments or cease producing certain products until the company can
pass an audit.
These interruptions can affect product supply chains, leading to unhappy customers
and lasting brand damage. In worst-case scenarios, lack of compliance can cause cash
flow problems. Outsourcing becomes less attractive for businesses trying to use their
talent budgets in highly regulated environments.
Despite the potential dangers, outsourcing does hold inherent value for businesses
operating in highly regulated industries. Successfully outsourcing key processes
also gives businesses a competitive edge, while still providing appropriate
compliance oversight.
/07CAN YOU AFFORD TO OUTSOURCE HIGHLY REGULATED PROCESSES?
Successfully
outsourcing key
processes also
gives businesses a
competitive edge.
9. Applying a strong understanding of regulatory requirements to
each part of an outsourced practice – including business processes,
staff training and performance metrics – is essential for companies
intent on outsourcing in highly-regulated industries.
Outsourcing is more than a tactical exercise in achieving cost reductions by passing
operations to third-party providers – it’s a strategic way for organizations to be more
competitive and responsive to future needs.
Companies operating in highly regulated industries need to take the long-term
approach to outsourcing, by making sure that service providers can sustain compliance
by building each of the following elements into their outsourced functions.
A proactive compliance framework
Outsourcing doesn’t absolve a business of its responsibility to comply
with industry regulations. Businesses that want to successfully outsource in
highly regulated environments must take a proactive approach to meeting their
obligations.
/09ENSURING COMPLIANCE IN OUTSOURCING
Outsourcing doesn’t
absolve a business
of its responsibility
to comply with
industry regulations.
1
10. These new arrangements must be modelled on compliance information published by
regulators, minimizing the margin for error and lowering the risk of penalties.
Building regulatory requirements into outsourcing frameworks also allows businesses
to eliminate inefficiencies and double-handling in business processes, which helps to
improve productivity and bring down operating costs.
Capable talent
Having a comprehensive compliance framework is not enough to
ensure outsourced operations meet all regulatory requirements; businesses
also need to ensure their providers employ skilled managers and teams capable
of understanding and applying regulatory protocols. Proper management reduces
operational risk and decreases regulatory scrutiny.
Managers of outsourcing engagements need the knowledge and experience to
maintain audit-proof levels of compliance – and to take action when workers breach
protocol. This is why it is essential for managers and their team members to receive
comprehensive training that reinforces the regulatory reasoning behind their daily
processes. Similarly, it is important for managers to follow rigorous procedures to
ensure all tasks and business processes are compliant and clearly documented.
/10ENSURING COMPLIANCE IN OUTSOURCING
Businesses need to
ensure their providers
employ skilled
managers capable of
understanding and
applying regulatory
protocols.2
11. Knowledge retention
High levels of turnover have an adverse effect on workers’ regulatory
knowledge and capabilities. For this reason, it’s important to make sure
workforce providers can retain regulatory knowledge within outsourced business
functions, especially over the long term.
A few keys to keeping regulatory know-how in the business is to offer a career path
with developmental opportunities to keep the workforce engaged and motivated.
By creating clear paths for career progression and offering benefits packages,
outsourcing providers can offer their workers stronger job security and motivation
to perform. This reduces workers’ incentives to leave and helps to keep valuable
compliance knowledge within the outsourced business process.
Positive workplace culture
Workplace culture is another aspect that is important for maintaining the
morale and quality of work among the workforce. Engaged employees are
easier to retain, but also more likely to take care in their work, which helps the
outsourced business process complies with regulation.
/11ENSURING COMPLIANCE IN OUTSOURCING
It is essential for
managers to receive
comprehensive
training that reinforces
the regulatory
reasoning behind their
daily processes.
3
4
12. For this reason, it is important to make sure outsourcing providers take an interest in
establishing positive environments for employees so they have greater ownership over
each outsourced business function’s regulatory compliance.
Strong accountability
Maintaining a high level of accountability in the eyes of regulatory bodies
is a good way to reduce unwanted scrutiny. If a regulator’s audit reveals that
all business processes are comprehensively documented, and that the records
show improvements in compliance, the regulator is likely to audit less frequently.
For this reason, it is important to make sure that outsourcing providers document their
compliance efforts and track improvements over time.
Internal audits are a valuable way to track a company’s compliance. By using regulatory
requirements to create audit checklists, providers can present managers of outsourced
functions and their teams with protocols that allow them to gauge how effectively
various processes comply with specific regulations.
Giving managers analytic tools also allows them to detect and remediate
noncompliance patterns that might develop over the long term. The ability to
anticipate potential protocol breaches helps safeguard outsourced business processes
against failure in future audits.
/12ENSURING COMPLIANCE IN OUTSOURCING
It is important to make
sure that outsourcing
providers document
their compliance efforts
and track improvements
over time.
5
14. Proactive regulatory management is essential for sustained
compliance when outsourcing in highly regulated environments.
The following five steps will help your outsourced projects meet and
maintain regulatory compliance over the long term.
1. Establish regulatory frameworks: It’s important that providers understand what
regulators expect of the business process you are outsourcing. Make sure your
provider uses guidelines and citations published by regulators as the basis for audit
checklists, and that outsourced business processes account for their compliance
with regulatory requirements.
2. Develop a well-trained team: Managers need to understand their regulatory
responsibilities. Make sure outsourcing providers offer managers and their
teams rigorous training in understanding and complying with regulatory protocols
and procedures.
3. Deploy knowledge retention strategies: By offering skilled team members
training and similar benefits to those enjoyed by full-time employees, as
well as building pathways for career progression, outsourcing providers can
reduce turnover, which helps retain valuable regulatory capabilities within
outsourced processes.
/14FIVE STEPS FOR EFFECTIVE OUTSOURCING IN HIGHLY REGULATED ENVIRONMENTS
Make sure
outsourcing
providers offer
managers rigorous
training.
15. 4. Create a compliant workplace culture: Managers and employees who are not
engaged in their roles are less likely to be committed to meeting requirements for
regulatory compliance. For this reason, it’s important to make sure your outsourcing
provider builds and maintains a positive workplace culture.
5. Maintain accountable processes: Compliance is an ongoing process, not a set-
and-forget solution. Check that your provider identifies relevant metrics in each
outsourced function; monitors these at least quarterly to mitigate the risk of failed
audits; and documents processes in preparation for any future audits.
/15
It’s important to make
sure your outsourcing
provider builds and
maintains a positive
workplace culture.
FIVE STEPS FOR EFFECTIVE OUTSOURCING IN HIGHLY REGULATED ENVIRONMENTS
16. Eye-care leader reduces turnover
of highly skilled staff
CASE STUDY:
/16
Aleading US eye-care
manufacturer was
employing college science
graduates as analysts in its
research and development
department. The workers
were responsible for testing
products such as contact
lenses to ensure they met
regulatory requirements for
quality and safety.
However, a lengthy training
process and dysfunctional
workforce model was causing
a high rate of turnover
– many graduates were
leaving voluntarily shortly
after training or were forced
out due to lack of career
progression in the role.
As a result, the company
was unable to retain the
knowledge of its highly skilled
staff despite the investment
in training.
The company asked
KellyOCG to review the
workforce model and
propose a solution that
would help retain skilled
workers, while improving
productivity in its core
quality and safety testing
processes.
Based on our
recommendations, the
company transferred
managerial responsibility
for its R&D employees
to KellyOCG. Using our
experience with business
process outsourcing, we
appointed an internal
manager to oversee the
laboratories and designed a
fresh approach to workforce
management that minimized
company restrictions.
We evaluated existing
contract and employment
arrangements and designed
a fresh approach to help
retain employees. The new
arrangements gave workers
greater job security, a full
benefits package, paid time
off and a degree of certainty
about the future of their
careers. This helped establish
a positive workplace culture
and reduced incentives for
workers to leave.
We also designed new
management processes
aimed at raising productivity.
Before we were engaged,
testing on clinical submissions
took teams around 14 days
to complete. Our rationalized
management approach
reduced this to seven days
within a year, and just four
days within two years.
The company’s quality and
safety control laboratories
now operate more effectively
and have higher retention
rates. Our involvement has
helped the company access
the long-term benefits of
developing and retaining
skilled workers, while
maintaining the flexibility and
cost-effectiveness of reduced
corporate headcount.
17. MICHAEL KOPER is the Manufacturing Solutions Architect for Business Process Outsourcing
practice of KellyOCG. Mike has over 20 years working in and consulting to the manufacturing
industry and has authored over 15 articles in trade magazines. Mike holds certifications as a
Manufacturing Engineer, Professional Engineering Manager and Technologist. Additionally,
Mike earned his degree in Engineering from Oakland University and a Masters in Management,
Nazareth College. He is a senior member of Society of Manufacturing Engineers as well as the
Society of Maintenance and Reliability Professionals.
JUAN LUEVANO is Director and Supply Chain Solutions Architect for the for Business Process
Outsourcing practice of KellyOCG. He began his career at Kelly working as a Lean implementation
manager for customer Delphi Energy. He has been with KellyOCG since 1999 and has held various
positions in operations, global account management and implementation. Juan attended the
University of Texas where he earned a Bachelor of Science in Economics, a Bachelor in Business
Administration in Finance, and minored in Latin American studies.
EXIT
ABOUT KELLYOCG
KellyOCG®
is the Outsourcing and Consulting Group of workforce solutions provider Kelly Services, Inc. KellyOCG is a
global leader in innovative talent management solutions in the areas of Recruitment Process Outsourcing (RPO), Business
Process Outsourcing (BPO), Contingent Workforce Outsourcing (CWO), including Independent Contractor Solutions,
Human Resources Consulting, Career Transition and Executive Coaching, and Executive Search.
KellyOCG was named in the International Association of Outsourcing Professionals®
2015 Global
Outsourcing 100®
list, an annual ranking of the world’s best outsourcing service providers and advisors.
Further information about KellyOCG may be found at kellyocg.com.