HIPAA laws related to fundraising became fully effective in 2013.  What protocols should be in place to maximize philanthropic opportunities under HIPAA? What compliance measures need to be in place and assessed to properly use protected healthcare information for fund raising.

IAS 8 spells out the specific principles, bases, conventions, rules and practices that are applied in preparing and presenting financial statements. When there is no specific standard that applies to a transaction, other event or condition, IAS accounting requires that Management apply judgment. But just exactly how do you do it?

The ultimate target in the pharmaceutical and medical device industries is to ensure patient safety within the entire product life cycle, from R&D to distribution.

This presentation reviews the current focal points from MHRA GMP inspections.

Quality of medical products (both drugs and devices) becomes a social and ethical responsibility as products are developed, produced and distributed for preventing, treating and reducing discomforts of diseases.

Overview:

The FDA's Design History Files, Device Master Records, Device History Record, and the EU's MDD TF/DD -- Documentation to meet their different purposes and device classifications.  This webinar will examine the existing and proposed requirements for the U.S. FDA's Design History File (DHF) per the CGMPs, 21 CFR 820.30 (j) -- including its derivitive documents, the DMR (Device Master Record) and DHR (Device History / Lot Record).  It will consider the European Union's MDD Technical File /Design Dossier requirements (similarities / differences), and evaluate the documents' differing purposes / goals, as well as the two  (FDA’s and EU’s) different device classification schemes.

Why Should You Attend:

One of our most popular webinars, continuously updated with the latest U.S. FDA and European  Union requirements. As U.S. companies go global, they must meet different product design documentation.  The Device (21 CFR 820) and Combination Products (21 CFR 4) cGMPs mandate Design Control and the Design History File (DHF).  In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical FiIe or Design Dossier.  Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD.  And how / where do the DMR and DHR fit?  Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.

Areas Covered in the Session:

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 (j) -- including its derivative documents, the DMR and DHR.  It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.  Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends. It will address typical DHF Table of Contents addressing the 9 must-have requirements of the cGMP guidelines; as well as the resulting DMR and DHR.

Then it will consider: Technical File or Design Dossier --  Table of Contents;  The 13 key requirements; The importance and usefulness of the "Essential Requirements";  Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed;  Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Learning Objectives:

•  What is the DHF, DMR,  and DHR.
•  Meeting the cGMP requirements.
•  The 9 key elements.
•  The Technical File / Design Dossier.
•  The 13 key elements.
•  Similarities / Differences in the two document systems.
•  Suggested SOP contents for both documentation systems.
•  Understand what is required to compile either / both.

Who Will Benefit:

•  Senior management in primarily in Devices and Combination Products Professionals
•  QA/RA Professionals
•  R&D Professionals
•  Engineering Professionals
•  Operations Professionals
•  Manufacturing Professionals
•  Document Control Professionals

Level:

Intermediate

For more detail please click on this below link:

https://www.complianceglobal.us/product/700098

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

The coral reefs' crisis is increasing, with the combined effects of natural and anthropogenic disturbances. It is predicted that coral reefs could extinct soon from the world. Bangladesh has only one coral Island named Saint Martin, locally known as 'Narikel Jinjira'. This is one of the most popular tourist spots in Bangladesh, entertaining thousands of tourists per year due to its unique landscape, blue water, and coral colonies' presence. This Island lost most of the coral in recent times. The coral reef ecosystem management needs to focus on the reformation of the legal and institutional frameworks for enhancing the local administration's capabilities to address the adverse effects of the stressors and promote the ecosystem services by improving the resilience. The study aims at analysing the existing institutional and legal frameworks for conserving the coral reefs. To collect data, fieldwork was conducted at Saint Martin Island and Teknaf Upazila. The related literature on legal documents was reviewed critically. It is found that despite having legal mechanisms and institutional frameworks, non-compliances with laws and poor coordination among different sectors are widespread, resulting in severe degradation of coral resources. In most of the laws, robust institutional arrangements were ignored. The study recommends integrating the legal and institutional frameworks governing the environment, tourism, and fisheries sectors. Effective marine governance, increasing coordination among different sectors, amending some existing rules, and activating MCS (monitoring, control, surveillance) system can improve the scenario.

This article provides an overview of the regulation of medical devices and drugs in the European Union and United Sates. It is important for all stakeholders involved in bringing a medical device or drugs to market to have an understanding of the regulatory requirements involved in this process. This article demonstrates that the regulation of these products is an extremely complex process.

Using objective measures of investor protections in 170 countries, I establish that the level of investor protection matters for cross-country differences in GDP growth: countries with stronger protections tend to grow faster than those with poor investor protections.

Overview:

A workplace emergency is an unforeseen event or occurrence that may threaten your employees, customers, or the public; disrupts or shuts-down your operations; or causes physical or environmental damage.

Some Examples of Emergencies are:

Man-made Events

Toxic gas releases
Chemical spills
Radiological accidents
Fires
Explosions
Civil disturbances
Terrorism
Workplace violence
Power Outage
Natural Events

Floods
Hurricanes
Tornadoes
Earthquakes
Drought
Fires
Ice Storms
Snow Storms
Dust/ Sand Storms

Why Should You Attend:

This webinar will discuss what Emergencies in the workplace are? Why having an Emergency Action Plan, (EAP) in place is important to you, you’re employees, and your business. This webinar will also give you the tools necessary to develop, and maintain your Emergency Action Plan, (EAP). Whether you are establishing your Emergency Action Plan, (EAP) for the first time or reinforcing an existing one in your workplace. This webinar will go through all the steps involved to complete your Emergency Action Plan program.What to include in the plan? How do you develop an evacuation policy and procedures? What role should employees play in your emergency action plan? What employee information should your plan include? What type of training do your employees need? How often do you need to train your employees? What are OSHA safety requirements for emergencies? What other OSHA standards address emergency planning requirements?

What to include in the plan? How do you develop an evacuation policy and procedures? What role should employees play in your emergency action plan? What employee information should your plan include? What type of training do your employees need? How often do you need to train your employees? What are OSHA safety requirements for emergencies? What other OSHA standards address emergency planning requirements?

Areas Covered in the Session:

What is a workplace emergency?
How do you protect yourself, your employees, and your business?
What is an emergency action plan?
What should your emergency action plan include?
How do you develop an evacuation policy and procedures?
What role should employees play in your emergency action plan?
What employee information should your plan include?
What type of training do your employees need?
How often do you need to train your employees?
What are OSHA’s requirements for emergencies?
What other OSHA standards address emergency planning requirements?

Learning Objectives:

Plan- when a crisis happens, few people can think clearly and logically
Prepare- to respond to an emergency or event before it happens, rather than after.
Train- great to have it all down on paper, but let’s put it to the test.

Who Will Benefit:

Safety & Health Management
Business Leaders/ Employers
Small Business Owners
Safety Professionals
Safety Consultants
Risk Management
Loss Prevention
HR/ Personnel
Management
Supervisors
Foremen
Facilities
Security

Level:

Beginner

For more detail please click on this below link:
https://www.complianceglobal.us/product/700049
Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Overview:

This webinar is intended to help you get familiar with the FDA-compliant management of medical device cybersecurity for regulatory purposes.

This webinar is further intended to increase our awareness that effective management of cybersecurity can greatly reduce the risk to patients by reducing the likelihood of compromising cybersecurity whether it is intentional or unintentional. 

This webinar will address the best practices for cybersecurity management for premarket submission purposes concerning medical devices containing software as well as software that is a medical device. 

The speaker will walk you through the FDA guidance practices.

Why Should You Attend:

To adequately manage cybersecurity for your medical devices containing software so that patient safety risks can be minimized.

Areas Covered in the Session:

• Laws and Regulations
• Definition
• Cybersecurity Principles and Functions
• Key Functional Requirements for Cybersecurity
• Regulatory Requirements
• Documentation
• Relevant and Applicable Standards
• Best Practices: Do’s and Don’ts
• PASS-IT Recommendations

Learning Objectives:

To understand and better manage cybersecurity for your medical devices containing software for premarket submission purposes.

Who Will Benefit:

• Regulatory Affairs Professionals
• Healthcare Professionals
• FDA Professionals
• Quality Professionals
• Medical Device Design Professionals
• Medical Device Scientists and Engineers
• R&D Professionals
• Complaint and Risk Management Personnel
• Consultants
• Contractors/Subcontractors
• CEOs
• VPs
• Clinical Affairs Consultants
• Other Interested Parties

Level:

Intermediate

For more detail please click on this below link:

https://www.complianceglobal.us/product/700078
Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Overview:

This webinar is intended to help you get familiar with compliance audits by the US Food and Drug Administration and Notified Bodies in European Union (EU).

This webinar is further intended to help you understand what you can do to best prepare for and manage the audits by EU Notified Bodies and FDA with increased awareness.

The FDA enforcement actions have recently increased. In EU, EU commission issued recommendation concerning unannounced audits by notified bodies in medical device industry.

As a medical device firm, you are subject to regulatory audits or inspection by the US FDA and EU notified body if you bring your medical device products into the US and EU countries allowing CE-marked products.

This webinar will cover the details of how you can proactively prepare for and manage the audits.

Why Should You Attend:

• To learn how to adequately prepare for and manage regulatory audits by the US FDA and EU notified bodies.

Areas Covered in the Session:

• Laws  and Regulations: US and EU
• Definitions
• EU Unannounced Audits
• Overview of both ISO 13485 and FDA 21 CFR 820
• Understanding Auditing Strategy
• Audit Objectives and Process
• Auditing Quality Management Systems
• Internal Audit Programs
• Quality Systems and Subsystems in ISO 13485 and under 21 CFR Part 820
• FDA and ISO 13485 training
• Common Mistakes/Misconception: How to Avoid Them
• Communication during Audit or Inspection: Dos and Don’ts
• Good Practices: Dos and Don’ts
• Conclusion

Learning Objectives:

This webinar will cover the details of how you can proactively prepare for and manage the audits.

Who Will Benefit:

• Regulatory Affairs Consultants
• Quality Site Professionals
• R&D Professionals
• Complaint And Risk Management Personnel
• Consultants
• Contractors/Subcontractors
• CEOs
• VPs
• Clinical Affairs Consultants
• Other Interested Parties

Level:

Intermediate

For more detail please click on this below link:

https://www.complianceglobal.us/product/700081

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Ai sensi della legge sui diritti d'Autore e del codice civile è vietata la riproduzione di questo libro o di parte di esso con qualsiasi mezzo, elettronico, meccanico, per mezzo di fotocopie, microfilms, registrazioni o altro, senza il consenso dell'autore e dell'editore.

Overview

For many organizations, the procure-to-pay cycle offers extensive opportunity for increased operational efficiency. However, it also provides potentially numerous opportunities for fraudsters to exploit control deficiencies in all three stages, purchasing, receiving and disbursements.
One common management mistake in the Purchase-to-Pay process is adhering to a reactive anti-fraud posture. A criminal act committed in, for example, the purchasing department through a kickback scheme, may be detected and dealt with on an “emergency” basis. Meanwhile, equally, if not more costly frauds may be going unnoticed in the receiving and account payable areas.
Anti-fraud experts urge a proactive, comprehensive P2P anti-fraud approach. It should be include assessing fraud risks in all three phases ... conducting regular audits that comprise testing for these risks and ... following up with effective internal control design and monitoring.

Why Should You Attend

Fraud is growing by a staggering 20% per year, according to the respected international fraud investigation firm, Kroll. The majority of all fraud, according to the Association of Certified Fraud Examiners is committed by employees.
Because most of the funds flowing out of the organization do so through the procure-to-pay cycle, it stands to reason that much of the growing fraud threat is centered on these critical closely-linked business functions.
This underscores the urgent need for management to understand the vast variety of frauds in P2P and to apply the necessary detection, audit, reporting and prevention measures.

Areas Covered in the Session

INTRODUCTION
•  Statistical overview of the fraud problem generally, and T&E fraud specifically
•  Who commits fraud
•  Overview of most common P2P fraud schemes
•  Case studies of purchasing, receiving and disbursement fraud
P2P FRAUD DETECTION AND PREVENTION
•  Red flags of key P2P frauds
•  Conducting a Fraud Risk Assessment report of the P2P Cycle
•  Audit techniques to identify P2P fraud red flags
•  Digging deeper for indicators of actual fraud
•  Reporting to Management
•  Remediating internal control deficiencies in the P2P process
•  Case studies of procurement, receiving and disbursement fraud

Learning Objectives

•  Understand how the most common procurement, receiving and disbursement fraud are perpetrated, including the latest technology-driven crimes that are costing organizations millions of dollars
•  Understand why purchasing, receiving and accounts payable employees commit fraud
•  Recognize the all-important red flags of common P2P frauds
•  Develop a knowledge base of P2P fraud detection tools and techniques
•  Begin creating a framework of effective anti-fraud controls

Who Will Benefit

•  Purchasing Managers and Senior Staff
•  Accounts Payable Managers
•  Shipping and Receiving/Supply Chain Managers
•  Accounting and Audit Practitioners
•  CFO’s and Senior Finance Staff
•  Internal and External Audit Professionals
•  Senior Financial Management seeking to reduce their vulnerability to costly frauds
•  Compliance and Ethics Managers
•  Security Personnel

A partire dall'esito referendario del 2011 e con la successiva attribuzione dei poteri di regolazione e controllo all'AEEGSI, il sistema idrico in Italia ha intrapreso un percorso di profonda evoluzione. Evoluzione che non ha solo riguardato aspetti tariffari/finanziari, ma ha anche coinvolto profondamente la sfera contabile: le società operanti nel settore infatti sono così chiamate a riflettere su quesiti attinenti la corretta modalità di registrazione dei ricavi, oppure la corretta modalità di trattamento contabile di poste tariffarie innovative. L'obiettivo dell'articolo è quello di esaminare le diverse problematiche di natura contabile associate alla regolazione tariffaria in essere, al fine di offrire uno strumento utile sia alla società idrica che al lettore del suo bilancio.

The Guia Regulatoria de Registro en Suramerica: Dietary Supplement, is an essential resource for any dietary supplements products company that wants to do business in the global marketplace. From Argentina to Venezuela, the Guide provides an updated overview of the regulatory environment for 10 countries. With more than 150 pages and organized with country-by-country chapters, the publication allows users to easily make comparisons among the countries.the Guia Regulatoria de Registro en Suramérica is an ideal starting point for individuals new to international dietary supplements regulations. It is also an invaluable tool for experienced professionals dealing with legal, regulatory, technical and marketing issues for the industry.

ABSTRACT

This is a very brief textbook that introduces a basic explanation about the relationship between Law and Economics. In Chile, the study of Economics for Law Schools began in the middle of 20th century using the denomination “ Economic Law”. The text assumes that the expression “ Economic Law” is not updated  and is not related to the current state of the art on law and Economics, Regulation and Antitrust law. The text, primarily oriented to students of Law Schools,  analyzes several areas of intersection between Law and Microeconomics, focused on the foundations, the main topics and the outcomes of the regulatory process.


Este es un muy breve libro de texto que introduce una explicación básica sobre la relación entre derecho y economía. En Chile, el estudio de la economía de las facultades de derecho se inició a mediados del siglo 20 utilizando la denominación "Derecho Económico". El texto supone que la expresión "Derecho Económico" no se actualiza y no está relacionado con el estado actual de la técnica en el Derecho y Economía, Regulación y Derecho de la competencia. El texto, orientado principalmente a los estudiantes de las facultades de Derecho, analiza varias zonas de intersección entre la Ley y Microeconomía, se centró en las bases, los temas principales y los resultados del proceso regulatorio.

Typical Elements Required to be Included in the Batch Production and the Device History Record in order to Accomplish a Quality and Cost Effective Review and Quality Management system based on current Regulatory Expectations in accordance with the submitted DMF and DMR (510K).

In this 21 st century, Lyophilization emerges to be a novel trend for the drying of pharmaceuticals and biological that are thermolabile or are unstable in aqueous form but stable for longer periods in their dried form. This article provides an overview on the process of lyophilization, how the freeze drying cycle is designed, discussing several important parameters which are important for understanding of this process as well as their role in the designing of an optimized freeze drying cycle, so that a robust and economical process of lyophilization can be developed which does not impact the product quality. It also describes the use of this process in various industries.

Overview:

Have you ever wondered about how FDA approaches CAPA (corrective and preventive actions) and complaint issues during inspections? What about how they manage those activities and what they are looking for? This webinar will provide clarity around those issues from a compliance expert with over 30 years’ experience in inspection and compliance management.

Why Should You Attend:

Many companies do not know what they don’t know when it comes to dealing with the FDA. By not understanding how FDA looks at CAPA corrective action and complaint problems, these companies oftentimes fail to manage inspections to reduce the risk of adverse findings. After the inspection, they fail to address key issues in response to fda 483s and Warning Letters. Here is your chance to better understand how FDA thinks and operates in managing these key inspection systems from a former medical device compliance insider.

Areas Covered in the Session:

CAPAs and complaints are key focus areas having GMP guidelines and this webinar will review the ins and outs of how to manage these systems and effectively address questions FDA will likely raise during inspections.

Learning Objectives:

•  Why CAPAs and complaints are so important to FDA
•  How to be prepared for an FDA inspection of these areas
•  How FDA uses data from inspections
•  How to avoid or reduce risk in managing product experience data of this sort

Who Will Benefit:

•  VP’s in Quality Assurance
•  Directors in Quality Assurance
•  Quality Managers
•  Quality Professionals
•  Small Business Owners

Level:

Beginner

For more detail please click on this below link:

https://www.complianceglobal.us/product/700088

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Overview:

Complex processes with unknown risks, incorrect quality problem definition, and ineffective follow up of issues impede Corrective and Preventive Action (CAPA) processes. Moreover, generation of numerous CAPAs with varying degrees of severity compounds the problem, as often the most critical event that requires urgent attention gets lost among non-critical events.

Establishing reliable root-cause analysis techniques help in identification of reasons enabling managers to prioritize CAPA. An effective CAPA process results in a reduction of issues, significant increase in preventive action through risk prevention that leads to better products and measuring  customer satisfaction.

Join Mike Micklewright, President at QualityQuest, Inc. for this webinar as he discusses strategies for creating an effective CAPA handling system and shares insights on:

CAPA as a means for continuous improvement of enterprise-wide quality processes
Avoiding CAPA overkill by taking the risk assessment process
Establishing a risk matrix to determine factors that need to enter the CAPA cycle
Risk Assessment and preventive actions in design and development
Need for reliable root cause analysis techniques
Leveraging sophisticated solutions to effectively handle CAPA

Why Should You Attend:

A new version of ISO 9001 will be published in 2015!
Risk will need to be addressed as never before!
So many tools – how do they apply and when do I sue them?
Long product development cycles are killing us – how can lean be leveraged to shorten lead times while still appropriately and adequately addressing risk

Areas Covered in the Session:

1)The “Standard Stuff”
2)Big Picture Risk
  SWOT
  Hoshin Kanri
  Contingency Plans
3)Medium Picture Risk
  Product and Process Design and Development
4)Detailed Picture Risk
  FMEA
  Mistake-Proofing
  Root Cause Analysis

Learning Objectives:

1) How CAPA should be used as the means for continuous improvement of enterprise-wide quality and lean processes
2) How to avoid CAPA overkill by taking the risk assessment route
3) The need for reliable root cause analysis techniques
4) How to leverage sophisticated techniques to effectively handle CAPA
5) How Lean and Risk Assessment can and should be used in Design

Who Will Benefit:

• VPs within Operations
• Directors within Operations
• Managers within Operations
• Quality Managers
• Engineering Managers
• Lean Managers
• Six Sigma Teams
• Lean Experts and Kaizen Team Leaders
• Quality System Management Representatives 
• Internal Auditors

Level:

Intermediate

For more detail please click on this below link:

https://www.complianceglobal.us/product/700076

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Analytical method validation is an important requirement to support the package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Back in 1987, the US Food and Drug Administration (FDA) issued its first guidance on analytical methods. The document was subsequently revised in 2000 and, despite the advancement in analytical methods, there were no further updates until 2014, when a new draft was issued for public comment. Following the period of review, in July 2015, the FDA issued a new version of the guidance. The third edition is titled Analytical Procedures and Methods Validation for Drugs and Biologics.

This article is exploratory in nature and it is multidisciplinary in its approach and follows on from the literature on regulation from Public Policy, Economic Analysis of Law and Law and explores the establishment of independent regulatory agencies as the main Competent Authorities in the regulation of the oil and gas industry, particularly in the upstream. Furthermore, the article explores the other models in which the regulation of the upstream is done by the Ministries of Oil/Energy and the National Oil Company.

This article explores the problems with the three models and examines examples of independent regulatory agencies in different jurisdictions. The jurisdictions under analysis in this article were not randomly chosen and illustrate some of the relevant issues about the establishment of independent regulatory agencies by exploring key jurisdictions, which established agencies as the Competent Authorities to regulate the oil and gas industry and abandoned the other two institutional alternatives. The article also looks at some of the challenges of the adoption of independent regulatory agencies from a comparative perspective

Abstract: Can sport "moves" be protected, as such? The absence of any original or creative form of expression because of their rulebound nature, the uncertainty of the end result of a game or competition and the lack of a scripted plot are commonly cited reasons which have led courts and commentators to espouse the view that sports are not copyrightable, as such. The Court of Justice of the European Union (CJEU) in 'Premier League v QC Leisure' confirmed this view.

Overview:

For many companies, Accounts Receivable Financing is the largest or second largest asset on the balance sheet. Therefore, any weakness in the financial controls for A/R could have a serious impact on the company’s financial statements. As well, since Accounts Receivable departments interact with almost every other department in the company, weak controls in A/R can lead to increased risk in other areas.

Why Should You Attend:

This session will provide you with the tools you need to establish and maintain strong accounting internal controls in the A/R department that meet Sarbanes-Oxley compliance and reduce risk and protect company assets. There will be opportunities for online discussion and questions.

Areas Covered in the Session:

Topics covered will include:

Establishing segregation of duties
Setting up cash application controls
Structuring bad debt reserve accounting
Improving credit policy
Introducing collateral controls
Developing invoice accuracy
Review the approval process
Examining the role of IT systems
Integrating SOX into daily routines

Learning Objectives:

Know how to establish, maintain, and improve Accounts Receivable controls that comply with Sarbanes-Oxley.

Who Will Benefit:

Credit Professionals required to co-certify
Accountants
Financial Managers
Financial Controllers
Company Executives
Anyone involved in the SOX A/R compliance process

Level:

Beginner

For more detail please click on this below link:

https://www.complianceglobal.us/product/700047

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

The analysis is focused on the national blockade of truckers which strongly affected Brazil between 21 and 31 May 2018, and its direct repercussions on the regulatory agency‘s behavior. To solve this crisis, significant part of the government‘s bargaining involved the participation of the National Agency of Terrestrial Transport (ANTT), which was responsible for the regulation of the minimal pricing policy for freight transportation throughout the country. However, the highly unstable regulations adopted by the Agency in just a few days have demonstrated the fragile autonomy of the entity, as well as revealed its de facto quasi-regulatory performance. The same perspective seems applicable to other Brazilian agencies, when analyzed the aggressive institutional pattern adopted by the Presidency, the Ministry and the Judiciary on regulatory issues, in order to weaken the agencies‘ independence and legitimacy.

This book explains the rapid evolution of the Blue Box municipal recycling program in Ontario between 1982 and 1994 and its social and environmental costs.

The origins of the Blue Box municipal recycling program in Ontario can partly be traced back to the early 1970s when concerns about litter problems were attracting the public's attention. In 1976, a law under the Environmental Protection Act was passed allowing the Ontario government to enact regulations banning non-refillable soft drink containers. However, the regulations banning non-refillables cans and new plastic PET bottles were never passed and instead in 1978 the soft drink industry convinced the Minister of the Environment to sign a “voluntary agreement” that soft drink companies and retailers would sell 75 percent of its soft drinks in refillable containers.

The 75 percent ratio for glass refillable soft drink containers was never reached though because the soft drink industry had trouble with the targets. The large pop producers and grocery retailers also had substantial connections to the Ontario Progressive Conservatives and made large annual donations to both the Liberals and the Progressive Conservative parties throughout the 1970s and the 1980s.

In the early 1980s, environmentalists renewed their push to get the Ontario government to enforce the 75 percent "gentlemen's agreement" on refillables. At the same time, the soft drink industry contended that consumers preferred disposables such as cans and plastic bottles. What the soft drink industry really wanted was "packaging freedom": in other words, freedom to use cheaper packages for their products, freedom to concentrate ownership in their industry, freedom to eliminate the independent bottlers, freedom to increase profits and freedom to start challenging the role of unionized bottling workers. In contrast, steel workers were arguing in favour of greater use of cans to provide a more secure footing for the steel industry. Meanwhile the aluminum producers and the canning industry wanted to develop new highly mechanized production lines that made full use of aluminum and would cut labour costs for the soft drink companies. The plastics industry wanted access to markets to sell plastic bottles to consumers and the independent bottlers said they wanted a better refillable system.

To resolve conflicts between these interests, a multi-stakeholder consultation process was established by the Ontario government in 1985, chaired by Professor Paul Emond of Osgoode Hall Law School. In this case, the former executive director of Pollution Probe, Colin Isaacs agreed to represent environmentalists. Isaacs decided that he would accept the concept of packaging freedom and greater reliance on plastic bottles and aluminum cans in return for greater support for recycling. Groups like Pollution Probe had been advocating recycling of newsprint, metal and glass for several years and using more valuable materials like aluminum to subsidize curbside recycling seemed like a way to break the barriers that had been encountered.

With Pollution Probe's support, participants involved in the multi-stakeholder consultation agreed to relax the refillable quota to 40 percent, that is, down from 75 percent, if the soft drink industry contributed $1 million to help set up Ontario Multi-Material Recycling Inc. or OMMRI and develop a Blue Box system (BBS). Eventually the amount of the contribution was increased to $20 million.

The consequences of this policy choice have been environmentally, socially and economically significant and have helped to spur a massive increase in the rate of soft drink consumption in Ontario, and a related increased in obesity among many adults and youths who consume sugar-laden soft drinks at a staggering rate. The book also explores how Ontario's BBS increased green house gas production related to aluminum production and energy consumption related to long-distance shipping.

Overview:

A discussion of good leadership skills (Behaviors, Relationships, Attitudes, Values, Environment), and its application to accelerating value-creation through inflection points.

Leadership is about inspiring and enabling others to do their absolute best together to realize a meaningful and rewarding shared purpose. While people do follow an engaging leader for a time, they devote themselves over time to the cause of a BRAVE leader who inspires and enables them in the pursuit of that cause. Those leaders pay attention to team building, values, attitudes, relationships and behaviors helping the team think through and act on five questions:

Why Should You Attend:

Leadership is about inspiring and enabling others to do their absolute best together to realize a meaningful and rewarding shared purpose. While people do follow an engaging leader for a time, they devote themselves over time to the cause of a BRAVE leader who inspires and enables them in the pursuit of that cause.

Areas Covered in the Session:

In this conversation, George Bradt explores how leaders help their followers answer five questions through what they say, what they do, and who they are with a particular emphasis on accelerating value-creation through points of inflection like a merger, acquisition or turn around.

Environment      Where to play? (Context)

Values                What matters and why? (Purpose)

Attitude              How to win? (Choices)

Relationships      How to connect?

Behaviors          What impact? (Implementation)

Learning Objectives:

Learn about inspiring and enabling others to do their absolute best together to realize a meaningful and rewarding shared purpose

Who Will Benefit:

Leaders
Line Managers
Functional Managers
Human Resource Professionals
Trainers
Consultants

Level:

Intermediate

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Regulation of the financial sector has always been a prime concern of states and the regulatory bodies which usually put in place. This work undertakes an overview of Malaŵi's financial sector and the dominance of banking. It discusses regulatory models and concludes that Malaŵi has a silo regulatory matrix. It distinguishes regulation and supervision and notes that in most jurisdictions these powers reside in the same body. It analyses the independence of the financial regulator and concludes that the regulator in Malaŵi is under the direct control of the political executive, factually and legally. It proposes a regulatory framework which takes cognizance of the political economy of the country. It also offers solutions on how some of the projected bottlenecks or hurdles can be overcome.

Annex 1 to the European Union Good Manufacturing Practice (GMP) guidelines is now under formal revision, with a concept paper issued during February 2015 and with a view to implement the new document during 2016. Annex 1 is a key part of European GMP for it affects the production and filling of sterile products. The document is also of global importance as manufacturing centers importing into Europe need to comply with the guidance. In addition, previous versions of the Annex have proven to be influential on other international regulators.

Advancement in the fields of material science, analytical methodologies, instrumentation, automation, continuous monitoring, feed forward/feed back control and comprehensive data collection have led to continual improvement of pharmaceutical tablet manufacturing technology, notably the multi-layer tablets. This review highlights the material attributes, formulation design, process parameters that impact the performance, and manufacturability of the multi-layer tablets. It also highlights on critical-to-quality elements that needs to be addressed in the regulatory submission.

This article provides an overview of the regulation of medical devices and drugs in the European Union and United Sates. It is important for all stakeholders involved in bringing a medical device or drugs to market to have an understanding of the regulatory requirements involved in this process. This article demonstrates that the regulation of these products is an extremely complex process.

The fact that foods can provide additional medicinal health benefits beyond basic energy requirements and nutritional needs for survival, has been proven through rigorous scientific researches over the years. Although Turkey is historically believed to be the ancient origin of a
decent number of fermented probiotic foods and beverages, there is still little awareness amongst the overall populace regarding the usefulness of these medicinal products also known as functional foods. Hence, the current review article discusses probiotics as a top notch variety of functional foods and encapsulates their history as well as some proven beneficial effects of some known probiotic microorganisms on human health. More importantly, greater emphasis is placed on elucidating scientific data on seven fermented traditional probiotic beverages of
Turkish origin namely boza, kefir, ayran, shalgam, hardaliye, koumiss and gilaburu juice. The paper concisely describes their main characteristics, probiotic microbiota composition, production techniques as well as nutritional properties and some potential health benefits derivable from their consumption.