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Killexams : Consultant Consulting course outline - BingNews https://killexams.com/pass4sure/exam-detail/CCI Search results Killexams : Consultant Consulting course outline - BingNews https://killexams.com/pass4sure/exam-detail/CCI https://killexams.com/exam_list/Consultant Killexams : Three Quick Steps to Better HazCom Training Three Quick Steps to Better HazCom Training

Three Quick Steps to Better HazCom Training

High-level considerations can go a long way to improving your facility’s effectiveness.

When I worked as a regulatory consultant, I conducted many site visits to evaluate companies for compliance with OSHA’s HazCom Standard. During many of those visits, I’d identify a disconnect. The facility’s management would have many of the right program elements in place, like a mostly complete library of safety data sheets (SDSs) and chemical inventory list, a written HazCom Plan (although not usually site-specific or detailed enough), and an obvious effort to make sure all hazardous chemical containers are labeled. But on the plant floor, when I’d ask an employee how they’d access an SDS, or who they could go to for more information about HazCom management practices, I’d get lots of blank stares and shoulder shrugs in response. The causes of that disconnect were problems in the facility’s HazCom training practices. 

Luckily, there are a few high-level considerations that can go a long way toward improving your training’s effectiveness. There are three simple steps you can take to build and maintain a HazCom training program that works. 

Train All Employees Who Need It 

The first step is to determine which of your employees need HazCom training. Some employers miss this part, because they’re so set on getting the training done, but don’t put enough thought into identifying all employees who need it. 

But how do we know which employees need training? It comes down to determining which employees may be exposed to hazardous chemicals at work, because 1910.1200 (b)(2) states that the HazCom Standard’s scope applies “to any chemical which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency.” In letters of interpretation, OSHA clarified that “foreseeable emergency” would include equipment failure, rupture of containers, or failure of control equipment, all of which could result in an uncontrolled release. 

This article originally appeared in the July/August 2022 issue of Occupational Health & Safety.

Wed, 03 Aug 2022 16:21:00 -0500 en text/html https://ohsonline.com/Articles/2022/08/01/Three-Quick-Steps.aspx
Killexams : A stitch in time: recovering distressed IT projects

Many relationships have a rocky patch. Most quickly recover. However, some can deteriorate to the point where separation seems like the only option. When the temperature is rising and heated words are exchanged, what can you do to recover a relationship or, if you are past the point of no return, end it with minimal pain and cost? William Hooper and Anthony Rance consider this question from the perspective of both expert and lawyer, sharing their own experiences of distressed IT projects.

It can be a common scenario in distressed IT projects. When issues occur, delays creep in and costs escalate, tempers can easily get frayed. Unless the cause of those issues is diagnosed early and a solution proposed, it can affect the relationship between the parties and erode the faith that once existed.

In one example, an organisation had de-merged from a larger parent, but the contracts had been novated without change. The operational separation of services had not been going well and the business was giving the CEO and CIO a very hard time. Jobs were on the line if recovery was not seen to be rapid and effective. This led to the CIO wondering whether matters were ever going to be resolved, or whether he should terminate.

Experienced lawyers will know that one should tread very carefully around termination. Terminating without valid grounds could amount to a repudiatory breach of contract, which will be a quick route into an expensive dispute. Therefore, before any irretrievable steps are taken, it often pays dividends to pause and to consider what is really going wrong. This is where independent expert assistance can prove invaluable. An expert consultant can bring operational experience of distressed projects to complement any legal guidance. A fresh pair of eyes may also see things that the project team may have missed and find solutions that no-one has thought of yet.

Feasibility

In such a situation, the best starting point is often the contract itself, particularly to get an understanding of the dispute resolution and termination clauses. Then the service schedules. Is the disputed area of performance a contracted service? Some clients think a service should be provided, without it being specified or paid for. Such a situation needs amendment of the contract and is not discussed further here.

The dispute resolution provisions may well set out a contractual mechanism for the agreement and implementation of recovery actions, to get a project back on track. Such a plan may for example be badged a “correction plan”, a “rectification plan” or a “remediation plan”. Whatever it is called, the purpose of such a plan is to help the parties to diagnose what is going wrong on the project, to agree steps to rectify matters and to establish measures and targets to ensure that recovery is achieved. It may also present a route to termination if the plan cannot be agreed or is not followed.

When recovery actions are being delivered, there can be a painful delay between intervention and response. The nightmare in a distressed service is for the customer to pull the plug when the right things have been done and results are just about to be seen. It should always be the baseline assumption that a recovery plan has a chance of succeeding and there needs to be commitment by both customer and supplier to supporting actions. This is the ideal. A short and confident intervention has every chance of getting a distressed project back on track.

In the case of our CIO who was under pressure, this was largely the course taken. Diagnosis showed that the underlying business-as-usual service was working well. The project manager for the demerger was not up to the job and was moved on. Governance was inadequate and was greatly enhanced. One service was hopelessly under-resourced and was accumulating an ever-growing backlog of unfulfilled requests. It needed properly designed tooling, a sensible plan, and the CIO to step back and give it a reasonable chance to deliver whilst explaining to the business. That worked. Stage two, once faith had been restored, was to establish a sensible contract that suited the needs of the de-merged business.

However, without proper oversight and effort, it can be all too easy for a recovery plan mechanism to escalate a dispute rather than resolve it. In another case, a supplier had taken on a desktop refresh project for an organisation which had an IT estate that had been heavily tailored by the incumbent supplier over many years. When the new supplier originally pitched for the job, it had not appreciated quite how complex and integrated the customer’s existing systems were, meaning that when the project started it quickly ran into problems, with delays and costs escalating rapidly.

These spiralling costs and unexpected delays led to the customer seeking to trigger a contractual correction plan mechanism, with the resulting plan going through numerous (but rejected) iterations. Ultimately, the customer elected to terminate the contract for a so-called “correction plan failure”. However, it appeared that it did so without sufficiently evidenced justification, meaning that its purported rejection of the correction plan was questionable. This then led to an expensive and hard-fought dispute over whether the customer had valid grounds to terminate.

Steps to resolution

When properly managed, a contractual recovery mechanism can provide a perfectly viable route to a satisfactory outcome, even if that outcome is termination.

In another case that the authors worked on together, a customer had all but lost faith in a supplier to deliver a solution with the required functionality and in anything like the cost and timescale that had been agreed at the outset. The prospect of termination was quickly looming.

Having analysed the contract, it was noted that there was provision for a rectification plan and an obligation to give the supplier a fair opportunity to recover. However, for such a plan to have any prospect of success, expert assistance was needed on what the customer should require in the plan, what targets should be set and what standards and measures would assure achievement.

It was necessary to give the supplier a demanding but reasonable target to aim at and to work within the contract’s dispute resolution terms. A literal practicing of the contracted approach indicated that a commonly encountered risk would arise, as it had in previous unsuccessful attempts between the parties. This was that the customer’s requirements would not be fully understood by the supplier, and thus the two would get into an unsatisfactory spiral in which each iteration of the plan missed what was really wanted, sapping energy and cost. The suggested approach therefore involved a liberal practicing of the contractually defined mechanism, in which the supplier would first produce a high-level approach and “outline recovery plan” that would be reviewed in a workshop with the customer, before being refined to deliver a detailed plan to be implemented (the “detailed recovery plan”). With the benefit of both legal guidance and expert technical assistance, the customer was able to put forward such an approach to the supplier.

The proposed approach gave the customer’s senior management comfort that either way they would achieve a viable outcome: either in the form of a re-energised project with a clearly defined plan and agreed targets, or by exposing the real cost, timescale and effort that would be needed to get the project to completion. From the supplier’s perspective, the opportunity to get to the real root of the issues was also appreciated. They had been having a thoroughly unpleasant time, haemorrhaging cash so the opportunity to bring clarity and focus to where the project was headed, and ultimately resolve the impasse and successfully deliver the contract, was gratefully received.

The initial workshop was seen as decisive, fair, and providing an achievable high-level approach. The customer’s project manager had been armed with clear guidance on what should be expected of both the outline rectification plan and the detailed rectification plan. The relationship between the two plans was also laid out.

Following the initial workshop, the supplier submitted their outline plan together with supporting artefacts. This was carefully reviewed by the customer’s project manager, using the required standards as the basis of assessment. This established material shortfall in several respects. The supplier was given feedback and invited to re-submit an amended draft. At that point however, the supplier disengaged from the rectification plan process and seemed to resign themselves to defeat. No further plan was submitted within the required timeframe, and the customer proceeded to terminate on robust grounds.

Conclusions

In distressed IT projects, it is normal to find that both parties have actions to take to make change sustainable. It is possible, for example, that the two parties have read ambiguous documents differently, which may be contributing to disputes over scope and responsibility. Such gaps need to be resolved and changes may be expensive for one or both parties. However, such issues do need to be grappled with or else they will fester and lead to dispute. Often, as the above examples illustrate, it can be helpful to pause and to take a step back, asking what is really going wrong on the project, before rushing forwards to termination.

When disputes emerge in an IT project, legal guidance is often crucial. In particular, a lawyer can help the parties to implement any applicable dispute resolution procedures in order to resolve their differences. Alternatively, if resolution does not prove possible, they can provide the necessary legal guidance (in a way that is legally privileged and protected from disclosure) to mitigate the risks of terminating the contract wrongfully, or even losing a termination right that had validly arisen.

Where there is a contractual recovery process that can be followed, it can also often be helpful to engage an independent technical consultant to ensure that the process is used to maximum effect. Such a consultant needs to have sufficient skill and experience to anticipate problem areas and to manage risks. Where the consultant has experience of legal disputes, such as that obtained when acting as an expert witness or expert determiner, they can also be alive to legal risks and challenges and support the legal team effectively. This is often a situation in which lawyer and operational consultant must work closely together throughout, to achieve a successful outcome.

Whilst undertaking such a rescue is not cheap, the costs of delay and wasted project expense (or indeed the costs of a contested termination) are frequently high enough to make intervention worthwhile. However, the intervention will need to be carefully handled if it is to have the desired outcome.

Anthony is a commercial litigator who advises on a broad range of disputes across a variety of sectors. He is regularly instructed to act on disputes arising out of commercial contracts, distressed IT and outsourcing projects, financial disputes, shareholder disputes, cases involving the misuse of confidential information and restraint of trade, disputes in the education sector and also negligence claims, including professional negligence.

William Hooper acts as an expert witness in IT and Outsourcing disputes and a consultant in service delivery. He is a member of the Society of Computers and Law and a director of Oareborough Consulting. He may be reached on +44 7909 958274 or William@Oareborough.com.

Thu, 28 Jul 2022 22:15:00 -0500 en-gb text/html https://www.weightmans.com/insights/a-stitch-in-time-recovering-distressed-it-projects/
Killexams : What the GRE Test Is and How to Prepare No result found, try new keyword!be all set,'" says Dennis Yim, director of live online courses with ... Lee, a career consultant and founder of PurposeRedeemed, a California-based career consulting firm, suggests focusing ... Sat, 30 Jul 2022 01:42:00 -0500 text/html https://www.usnews.com/education/best-graduate-schools/articles/what-the-gre-test-is-and-how-to-prepare Killexams : Steps to Equipment Qualification

 VALIDATION

(click to enlarge)
This is an example of a table that would be included in a qualification protocol in a prerequisites test section. An official copy of the protocol is printed and the tester fills in results of the procedure for the test section performed.

Equipment qualification is a necessary and critical step in ensuring that a product or service is provided accurately and consistently with requirements aligned with medical device manufacturing and testing. This is especially critical for the medical device industry because the medical device manufactured by a company is considered a piece of equipment and requires qualification, as much as other equipment and instruments involved in manufacturing. Verifying prerequisites before qualification ensures a safe and smooth qualification process. A prerequisite in an equipment qualification is a documented verification intended to demonstrate that everything is in order prior to initiating the execution of the qualification section.

For medical device companies, using prerequisites translates into less time and money spent on avoidable delays. Because the requirements for a piece of equipment or a device can vary widely from company to company and even between pieces of the same type of equipment, it is important to devise a universal set of prerequisites that will address all potential trouble areas. Device OEMs and device-testing facilities need to understand how prerequisites fit into an equipment qualification, and need to know what should be Checked during prerequisite verifications in an equipment qualification. They should also be able to outline a universal set of prerequisites.

Prerequisites in an Equipment Qualification Protocol

Setting up equipment in a medical device manufacturing facility includes ensuring that the equipment will safely and consistently work as intended. To do this, it is necessary to verify the following actions:

  • That the equipment is installed according to the manufacturer's instructions.
  • That the equipment is operated properly and consistently.
  • That the equipment performs within the requirements determined by the facility.

To cover all of the necessary criteria, equipment qualifications are typically organized by separating the protocol into three sections: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Because the IQ, OQ, and PQ are performed separately, each should have its own set of prerequisite verifications. Because the equipment requirements at each of the qualification stages are different, the prerequisite requirements at each of the qualification stages should be different as well.

What to Verify during Prerequisite Testing

The general goal of prerequisite testing is to ensure that items that commonly cause execution to be delayed or repeated are in order prior to starting the qualification. Because of variations in equipment and differences in how facilities operate, using the exact same prerequisite verifications may not always be the best approach.

For prerequisites to significantly help streamline the qualification process, they have to be tailored to fit the specifics of both the equipment and the facility. As a whole, it is easy to overlook potentially important prerequisites. Therefore, it is often helpful to separate them into categories and address them one at a time. With a good understanding of the categories, the process of tailoring the verifications to suit a specific piece of equipment at a specific facility will be much smoother. Although it is nearly impossible to cover all prerequisite verifications, some of the most common prerequisite categories are presented and explained in the following paragraphs.

Procedure Prerequisites

Procedure verification includes any procedure that is required for operation or maintenance of the equipment as well as any sampling or testing procedures required to obtain and analyze the protocol samples. Each of these procedures has typical items that need verification, such as the status of the procedure, the title, and the document number. Specifications vary depending on the section of the protocol the verification is being written for (i.e., IQ, OQ, or PQ). For example, during the IQ, it might be acceptable for the procedures to still be in draft form. But by the time the PQ section is going to be executed, the procedures must be approved documents.

Performing procedure verification could be cost-efficient for a company. For example, a medical device facility brought in personnel to perform the time-consuming task of collecting microbial samples for a qualification. When the samples arrived at the laboratory, they realized that the testing procedure for the samples was still in development. None of the samples taken were usable and the entire collection process had to be repeated once the testing procedure was approved. Because of the delays, the launch of the medical device into the market had to be postponed. The expense of the wasted man-hours and supplies and the delay of the launch could have easily been avoided by a procedure verification prerequisite.

Training Verification

(click to enlarge)

Procedure prerequisite specifications in equipment qualification.

The importance of verifying the training of operators and test personnel is a universal prerequisite throughout the various types of validations and qualifications. For equipment qualification, it's important to verify that the personnel operating the equipment (in addition to the personnel executing the protocol) have the training required to successfully perform the necessary tasks according to the currently acceptable method. Additionally, the personnel executing the protocol should be similarly trained.

Picture executing a performance qualification of an autoclave for which the operator doesn't know how to control the equipment, and the importance of verifying operator training becomes clear. What may not seem as clear is why it is important to verify the training of the qualification test personnel. A medical device manufacturer learned the importance of test personnel training during the qualification of a freezer. The freezer qualification included a 72-hour temperature mapping, which required monitoring and recording the temperature in different quadrants of the freezer at specified time intervals for a three-day period. During an audit, it was discovered that the data were not collected for the full 72 hours. An investigation concluded that the error was due to the fact that the testers who set up the mapping were trained on an earlier revision of the protocol and didn't realize the time interval had changed. For this company, the small amount of time that would have been needed to execute a prerequisite seems well worth it after being set back three or more days because of the need to investigate and repeat the test.

Utilities Verification

Although not actually a part of the equipment, utilities are essential to its operation. Equipment cannot run without electricity, compressed air, gas, water, etc. Utilities that should be Checked include any utility that is required to execute the protocol and has the possibility of not being available or not being available at the required level.

An example of the benefit of performing utility verifications was seen during the qualification of equipment designed to weld the seam of a medical device. For the equipment to produce a successful weld, it was critical that the laser power supply meet very specific electrical requirements. During the qualification, multiple unsuccessful welds were observed. After a lengthy investigation, it was discovered that the problems were caused by a variation in the electricity feeding the laser. Although the problem was identified, the time needed to correct the problem and rerun the test was costly and could have been avoided had the utility qualification of the electrical system been performed prior to starting the testing.

Test Instrument Prerequisites

Instituting test instrument prerequisites is a simple way to eliminate costly delays and misunderstandings. The items that should be tested in this section include any instrument or piece of equipment that is required during the execution of the protocol. Some examples of instruments or equipment that are typically Checked in test instrument verification include voltage meters, particle counters, and scales. Testing and sampling instruments and equipment are often used by many people and often require calibration. Typical items that benefit from prerequisite testing include the availability or location of the instrument or equipment and its calibration status for the expected duration of the qualification execution. Just imagine the headache it would cause, if, when it came time to start a qualification, you realized that your scale was out of calibration or the particle counter you ordered a month ago never arrived. Making arrangements for calibration or tracking down an order often involves time-consuming activities (e.g. getting approvals, contacting customer service representatives, and tedious paperwork). Such tasks are time-consuming in general, so don't add to the burden by waiting to do them until it's too late to resolve the issue without holding up the qualification. Performing prerequisites allows you to address the items before they start causing delays.

An incident during a qualification of an incubator at a contract testing laboratory shows how test instrument verification can make a difference in a timeline. Temperature mapping was included as part of the qualification. After completion of the qualification, it was discovered that some of the data loggers used during the mapping were out of calibration. The calibrations were scheduled and performed, but the mapping had to be repeated once the data loggers were received back from calibration. The hassle of additional scheduling and the delays incurred could have been avoided had the contract testing laboratory performed a test instrument verification that included the data loggers.

Equipment Status Prerequisite

The purpose of equipment status prerequisite testing is to ensure that the equipment being qualified is installed and ready for qualification. As with procedure verification, different requirements or specifications are typically desired for different sections of the qualification. For example, it might be necessary for the equipment to be set up, calibrated, and ready to run during a PQ. However, for the IQ, it's only necessary for the equipment to be installed. Another possible inclusion in equipment status verification is the availability of the equipment for use. Unlike process validation, which cannot begin until a process has been developed, equipment qualification protocols are sometimes written before the equipment is even received. As a result, a protocol can be ready for execution long before the equipment has arrived and been installed.

Recently, the qualification of a building management system at a medical device facility was scheduled to begin, and consultants were hired to execute the protocol. When the consultants arrived at the facility to begin the qualification, they found out that an ancillary electrical panel had not been installed because it was on back order. If the equipment status had been Checked prior to the qualification, the cost and time of the additional on-site visit by the consultants in order to reassemble the team could have been avoided.

Additional Benefits of Prerequisites

Documentation of prerequisites creates a system that actively tracks future problems, not just problems that have already occurred. When combined with the existing methods of identifying trouble areas of the quality system, prerequisites provide a little extra help in meeting the overall goal of preventing problems rather than just reacting to them.

Adding prerequisites to a validation or qualification program also helps OEMs prepare before an audit. By performing these simultaneous “spot checks” or verifications of the quality system, it is possible to generate trends in the quality system. The additional method of locating such holes and inconsistencies helps a company understand the areas to focus efforts prior to an audit instead of after an auditor has found the problems.

Conclusion

Incorporating prerequisites into an equipment qualification ensures that equipment is ready to run consistently and reliably. Moreover, it ensures that the equipment can pass the testing outlined in the protocol with fewer failures, investigations, or retesting. The ability of prerequisites to streamline the execution of a qualification, with the added bonus of the ways that they benefit a quality system, demonstrates the value of incorporating prerequisites into an equipment qualification. Having a clear understanding of the benefits and being able to apply them to your facility can ensure smooth, cost-effective qualification efforts.

Jennifer Medlar is a consultant for Advanced Biomedical Consulting LLC (ABC; St. Petersburg, FL), and Nancy Cafmeyer is a project manager at the company. Contact them at [email protected] and [email protected].

“Current Good Manufacturing Practice for Finished Pharmaceuticals,” Code of Federal Regulations, Part 211, Title 21, Rev. April 2006.

Food and Drug Administration (FDA), “Guideline on General Principles of Process Validation,” Rockville, MD, 1987.

N Cafmeyer and JM Lewis, “Process Validation Prerequisites 101,” Medical Device & Diagnostic Industry, March 2008.

Copyright ©2009 Medical Device & Diagnostic Industry

Tue, 02 Aug 2022 12:00:00 -0500 en text/html https://www.mddionline.com/equipment/steps-equipment-qualification
Killexams : Judge mulls challenge to DeSantis’ restrictions on corporate training

TALLAHASSEE — A federal judge on Monday questioned part of a new Florida law that restricts the way businesses can address race-related concepts in employee training, as he weighed a request to block the measure.

The law (HB 7), passed during this year’s legislative session, was a top priority of Gov. Ron DeSantis, who dubbed it the “Stop Wrongs to Our Kids and Employees Act,” or Stop WOKE Act.

A group of businesses and a consultant filed a lawsuit in June challenging the measure’s constitutionality. The plaintiffs are an online honeymoon-registry company, a Ben & Jerry’s franchisee and a workplace diversity consulting company and its founder. All of them require or provide training sessions for workers on Topics such as diversity, equity and inclusion.

Attorneys for the plaintiffs argued that the law violates the First Amendment and are seeking a preliminary injunction to block its enforcement, leading to a hearing Monday before Chief U.S. District Judge Mark Walker.

The law lists a series of concepts that would constitute “discrimination” if included in required employee training. For instance, the law targets training exercises that would “compel” an employee to believe that they bear “responsibility for and must feel guilt, anguish, or other forms of psychological distress because of actions, in which the individual played no part, committed in the past” by members of the same race or sex.

Walker did not rule Monday, pledging to “move swiftly” on issuing a written order. But during a roughly two-hour hearing, Walker appeared to favor arguments by the plaintiffs’ lawyers that the measure targets speech that DeSantis and state leaders find objectionable.

Walker pointed to DeSantis’ Stop WOKE moniker for the law.

“We are attacking and going after a particular construct,” Walker said of the law, which the Legislature formally titled as “Individual Freedom.”

In a 47-page complaint, the companies and consultant spelled out ways that the law would hurt their businesses, including having to change the ways they conduct training sessions and losing clients.

“Though they do not work together, all plaintiffs are deeply committed to addressing racial and structural inequality and historical privileges associated with gender, sexual orientation, and skin color, no matter how upsetting or uncomfortable facing such Topics may be,” the complaint said.

DeSantis, Attorney General Ashley Moody and members of the Florida Commission on Human Relations are named as defendants in the lawsuit.

John Ohlendorf, an attorney representing the state, argued that the law is intended to protect employees from being “a captive audience” to such training exercises.

“The state of Florida does not have a compelling interest in targeting speech because it doesn’t like the content,” Ohlendorf said Monday. “I do think the state of Florida has a compelling interest in preventing employers from forcing employees to listen to speech that suggests one race is inherently superior to another.”

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Walker pushed back on the state’s arguments and appeared to side with an assertion by the plaintiffs that the law is vague and difficult to understand, based on a standard of person of average intelligence’s comprehension.

Walker focused on a part of the law that would label training discriminatory if it led an employee to believe that a person of “one race, color, sex, or national origin cannot and should not attempt to treat others without respect to race, color, sex, or national origin.”

“Apparently I’m a person of below-average intelligence, because I have no idea what that means,” Walker said.

The measure was one of the most-contentious bills during the 2022 legislative session. A separate federal lawsuit challenges parts of the law dealing with how race-related concepts can be taught in schools. Walker in June declined a request by plaintiffs in the education lawsuit to bar the law from going into effect.

Attorneys for the plaintiffs asking Walker to stop enforcement of the business-related part of the measure described a “chilling” effect that it has had on companies since it took effect July 1.

Shalini Goel Agarwal, an attorney representing the businesses, argued Monday that DeSantis has shown a pattern of “using the levers of state power” to punish the actions of businesses that he disagrees with.

“Our diversity, equity and inclusion trainer (plaintiff) says that so many of her own clients … have said that there is an amazing chilling impact. Because all these companies who, as a standard, do these types of trainings are feeling like, ‘We don’t know if we can do them anymore and we don’t know if we can say anything about it because we’re concerned about kind of a culture of retribution and retaliation that has been exerted against companies in Florida,’” Agarwal told reporters after Monday’s hearing.

BY RYAN DAILEY

Mon, 08 Aug 2022 08:27:00 -0500 en text/html https://www.tampabay.com/news/florida-politics/2022/08/08/judge-mulls-challenge-to-desantis-restrictions-on-corporate-training/
Killexams : Evans Consulting Acquires Global Dynamics International, a Market Leader in Intercultural Competence and Global Leadership Development

Press release content from Globe Newswire. The AP news staff was not involved in its creation.

FALLS CHURCH, Va., Aug. 09, 2022 (GLOBE NEWSWIRE) -- Evans Consulting, an award-winning management consulting and government contracting firm, has finalized its acquisition of Global Dynamics International Inc. (GDI) ( global-dynamics.com ). 

Global Dynamics International Inc. is a leading provider of cross-cultural competence, global mindset, diversity and inclusion, unconscious bias, global leadership, team building, virtual workforce effectiveness training and coaching and research designed to meet the ever-changing needs of today’s global and multi-cultural organizations. Evans co-owners, Bob Etris and Jack Moore, worked closely with GDI’s Founder and President, Neal Goodman, in finalizing the deal. 

“We couldn’t be more pleased to add GDI as a division of Evans Consulting,” said Moore. “Our shared values of people, service, and integrity create a foundation for continuing to build on GDI’s history of success in the commercial markets. Expanding our portfolio of human-centered consulting services that equip leaders and teams, at any level of an organization, to work effectively together is critical to our continued growth and success.  GDI’s unique capabilities and value proposition help us do just that.” 

For over 34 years, GDI has empowered the world’s finest organizations (including the majority of the Fortune Global 1000) in more than 60 countries to overcome the challenges of globalization and virtual environments and to leverage the power of diversity and inclusion.

“Our mission at Evans Consulting is to develop healthy organizations and communities that enable people to thrive. GDI’s core services complement our mission. It couldn’t be a more seamless fit to our organization,” said Etris. 

Through the planning and design of the eventual sale of GDI, Goodman was drawn to Evans’ collaborative culture and relentless focus on addressing the human and technical sides of organizational change. This, in conjunction with Evans’ human-centered approach, offered GDI an environment where Neal’s legacy and commitment to client success will continue to thrive. 

“GDI represents my life’s work, and I am thrilled it has a home with a shared sense of purpose, culture, and commitment like Evans,” said Goodman. “With the kind of talented leaders and organization Evans has, I’m excited about the possibilities of what Evans can do to take GDI to even greater heights!”

With the acquisition of GDI, Evans has enhanced its portfolio of global services that includes world-class executive coaching and leadership development services through its Global Coaches Network (GCN -  globalcoaches.com ), as well as the intercultural competence and diversity and inclusion development offered through GDI. Neal will continue to work in partnership with Evans as an advisor and trainer while publishing articles for  Training Magazine and periodically speaking at conferences and tradeshows.

About Evans Consulting: 

Evans Consulting is an industry-leading management consulting and government contracting firm. Our solutions and products are designed to assist with specific challenges related to organizational change and transformation, leadership development, technology integration, and strategic growth, with a unique, human-centered approach. For more information, visit  evansconsulting.com.

Media Contact

Bob Etris, betris@evansconsulting.com, (703) 927-6568

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Tue, 09 Aug 2022 05:03:00 -0500 en text/html https://apnews.com/press-release/globe-newswire/government-contracts-8a2626c1017df3538d6f60b216c3f013
Killexams : DeCoteau awarded Certified Radio Marketing Consultant

The Radio Advertising Bureau has announced that Jackie DeCoteau, marketing representative at KSJB/Mix 93.3 Radio, has earned the designation of Certified Radio Marketing Consultant.

The CRMC is an accreditation establishing the recipient as a modern-day radio marketing professional who understands the needs of advertisers.

Jacke DeCoteau.jpg
Jackie DeCoteau

Contributed / KSJB/Mix 93.3 Radio

To earn the CRMC, DeCoteau undertook a course of marketing and advertising study that culminated in a comprehensive online examination.

DeCoteau can be reached at jdecoteau@ksjbam.com or 701-252-3570.

Thu, 04 Aug 2022 09:12:00 -0500 en text/html https://www.jamestownsun.com/business/decoteau-awarded-certified-radio-marketing-consultant
Killexams : Blue Diamond Ventures Inc. Completes Acquisition of ICS Consulting Service

Press release content from KISSPR. The AP news staff was not involved in its creation.

08/02/2022, Vancouver Canada · V6E 4A6 // KISS PR Brand Story PressWire //

Contract Compliance, Audits, Training and Seed-to-Sale Support
ICS adds capability and revenue to the BLDV portfolio

Blue Diamond Ventures Inc (OTC Pink: BLDV) and ICS Consulting Service LLC (ICS) have officially completed the acquisition transaction and ICS is now a wholly owned subsidiary of Blue Diamond Ventures Inc.

“We are extremely excited about ICS and Jenny Germano joining the Blue Diamond Team. ICS brings a wealth of expertise and a proven track record of delivering unparalleled compliance services to the cannabis industry,” said Yale Peebles. “The combination of ICS with our existing holding Harvest 360 provides a synergistic value we are looking to build upon.”

ICS Consulting Service LLC has been making an impact in the cannabis industry in emerging markets as well as some established ones. Formed in 2015, ICS is a known leader in compliance within the cannabis industry and Jenny Germano has become one of the industry’s most important voices in the realm of compliance. “BLDV provides the support to take ICS to the next level,” said Jenny Germano, Founder & President of ICS. “I have 13 years of regulated cannabis compliance knowledge based on actual operational experience to support this effort.”

ICS Consulting Service takes a different approach to compliance than other companies in the market. The auditors and trainers at ICS are trained professionals that each have over a decade of direct operational experience and provide a real educational resource for the operators to Improve their performance. ICS strives to implement and support a Culture of Compliance inside all types of cannabis organizations.

Contract Compliance services from ICS provide small and midsize operators a top tier solution at a lower cost alternative to hiring expensive compliance professionals to run an in-house department. ICS Consulting Service LLC and Harvest 360 Technologies LLC will be showcased in Schaumburg IL at the CannaTech Show this week on August 3rd and 4th.

About BLDV: Blue Diamond Ventures, Inc. offers companies a wide array of services related to the Medical and Adult-Use Cannabis industry. Our experience provides services for startups as well as established players in the Cannabis space. Our knowledge and ability to provide competitive sustainable advantages are as diverse as our clients and marketplace we operate in. Through a vast network of strategic partnerships, public/private alliances and real world practical business experience Blue Diamond Ventures, Inc. is a valuable resource to companies in the Cannabis marketplace.

Contact: Blue Diamond Ventures Inc.
Josh Alper CSO / Investor Relations josh@repla.com
www.BLDV.usinfo@bldvinc.com

About ICS Consulting Service

ICS specializes in Compliance based services, such as Third-Party State Regulatory Audits, State Cannabis Policy Making, License Application Support, Technical Writing, Standard Operating Procedures Development, Compliance Operations Training, Employee Retention Solutions, Employee Onboarding, Manufacturer Food and Product Safety Certifications/ServSafe® Instructor, OSHA certified, Licensed Facility Build-out Support, HR Compliance and Operational Compliance Readiness Support.

Company Inquiries:
ICS Consulting Service LLC
Jenny Germano President & Founder
jenny@icsconsultingservice.com

www.icsconsultingservice.com

Safe Harbor:

This press release contains forward-looking statements. Such forward-looking statements are subject to several risks, assumptions, and uncertainties that could cause the Company’s actual results to differ materially from those projected in such statements. Forward-looking statements speak only as of the date made and are not guarantees of future performance. We undertake no obligation to publicly revise any forward-looking statements.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/132547

Source: Newsfile Corp.

Release ID: 337427

Original Source of the original story >> Blue Diamond Ventures Inc. Completes Acquisition of ICS Consulting Service

This content is published on behalf of the above source. Please contact them directly for any concern related to the above.

Tue, 02 Aug 2022 02:49:00 -0500 en text/html https://apnews.com/press-release/kisspr/business-ac5b2bb97d8d2dfb5764cec84032cbfc
Killexams : An Introduction to the Medical Device Regulation Training Course: London, United Kingdom - August 1-3, 2022

Dublin, July 22, 2022 (GLOBE NEWSWIRE) -- The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.

This is an excellent introduction from leading experts in the field and delegates should expect three days of intensive training.

This seminar provides an invaluable overview of the European Medical Device Regulation (MDR). The interactive programme will explain the new legislation and which products are covered, the involvement of Notified Bodies and how to choose one and will outline a manufacturer's responsibilities. It will also cover the documentation necessary to apply for the CE mark.

Who Should Attend:

Past delegates include those working in regulatory affairs, pharmacovigilance, quality assurance and technical support. This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.

Key Topics Covered:

What is a medical device?

Europe and the MDR - overview of the regulations applicable for bringing a medical device to market

Economic operators and other parties

  • Who are they?
  • How do they interrelate?
  • What are their responsibilities?

Classification of devices

  • What are the classes and how do we classify devices?

Conformity assessment procedures

  • The routes to CE marking
  • What is required for each class of device?

Workshop 1: Classification

Manufacturers' responsibilities

  • Technical file and design dossier requirements

Quality systems

  • EN ISO 13485: 2012 and 2016
  • The requirements for a quality system

Labelling of devices

  • Use of language and symbols
  • Instructions for use

Workshop 2: Labelling

Clinical evaluations

  • European regulatory environment
  • When are clinical investigations necessary?
  • What is required by the competent authority, Ethics Committee and Notified Body?

Workshop 3: CE marking

Medical device vigilance

  • Adverse event reporting
  • Reporting requirements
  • Post-market surveillance (PMS)

Workshop 4: Vigilance

Drug/device combinations

  • Drug or device?
  • Examples of classification

Devices incorporating material of animal origin

  • Animal-derived materials legislation
  • Directive 2003/32/EC

The revision to the regulations for medical devices

Speakers:

Janette Benaddi
Director of Clinical & Consulting Europe
NAMSA

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years' experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

Will Burton
Director
Russell Square Quality Representatives (RSQR) Ltd

Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA). He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health's Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.

Theresa Jeary
Technical Manager for Medical Devices
Lloyds Register Quality Assurance (LRQA)

Theresa Jeary holds a Master's Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.

Theresa has over 25 years' experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been a part of the team for many commercially available medicinal and medical device products.

Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.

Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the "fence" and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).

Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.

At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.

For more information about this conference visit https://www.researchandmarkets.com/r/uqxs9m

CONTACT: ResearchAndMarkets.com
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Fri, 22 Jul 2022 00:36:00 -0500 text/html https://www.benzinga.com/pressreleases/22/07/g28167208/an-introduction-to-the-medical-device-regulation-training-course-london-united-kingdom-august-1-3-
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