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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 Tested 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:
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 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.
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.
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 Tested 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 Tested 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 Tested 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.
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
Himachal Pradesh Board of School Education (HPBOSE) has declared the HP Board Class 12 Supplementary examination result for August 2022 session today, October 7. Students who took the supplementary examination can check the result on the official website at hpbose.org. Candidates can check their HPBOSE class 12th Supplementary results through their roll number.
HP Board 12th supplementary Result 2022: Know how to check
Visit the official website at hbpbose.org
On the homepage, click on the result tab
Next, click on “12th (Compartment/Improvement/Additional/Diploma Holder(Re-Appear)) Examination Result, August-2022”
Enter your roll number and click on search button
HP Board 12th supplementary result 2022 will appear on the screen
Download it and and take print out for future reference.
A financial advisor is a professional who works independently or is employed by a financial firm that gives guidance about investing and money decisions. Advisors may make money by charging clients a commission for trades or an advisory fee for managed accounts.
Not everybody in the financial advisory space has the same knowledge, background, or skills. Here we describe some key factors that you should look out for to help make sure that your financial professional is qualified to good a job.
The financial industry is strictly regulated in most countries. While everyone is free to share their opinion on the stock market, most countries have strict rules limited who can supply financial advice in a professional capacity. These rules are intended to protect the public from self-serving, unethical, or uninformed financial guidance.
In the United States, financial advisors are regulated according to the type of service they provide, whether that means accounting services, investment information, or financial planning. In addition, they may also be required to register with the Securities and Exchange Commission or another regulator at the state or federal level, depending on the type and value of the assets under their management.
Below, we cover four important qualifications to look for in a professional financial advisor:
While there is no legal requirement to go to college, it would be difficult to start a career in finance without at least a four-year degree.
Most brokerage firms require that all new financial advisor applicants have at least a bachelor’s degree from an accredited educational institution. The major can vary, but most are in finance, marketing, or business. A Master's in Business Administration (MBA) is not required but certainly adds to the financial advisor’s resume.
There is some disagreement about the correct spelling for this common financial term. Many financial firms default to the familiar "advisor," while the Securities and Exchange Commission uses the less common "adviser." No matter how you spell it, the professional requirements are exactly the same.
In order to sell securities, financial advisors are required to pass and possess the General Securities Representative license, also known as the Series 7. This test covers all the basic investment knowledge and regulations that financial advisors must know. There is also the Series 63 license, known as the Uniform Securities Agent State license. This allows advisors to conduct business across multiple states.
Advisors who wish to charge advisory fees must also take the Series 65 test or the Uniform Investment Advisor Law exam. These three licenses are held by most financial advisors in the industry.
There are many other licenses that allow advisors to sell additional products. Many insurance agents get their state’s life, health, and variable insurance license, which permits them to sell life insurance, health insurance, long-term care, and variable annuities.
There are several other investments that require licensing before they can be sold, such as managed futures that require a Series 31, or commodities that require a Series 3.
FINRA may waive certain test requirements for qualified candidates, such as those with foreign securities experience, or an acceptable substitute exam, such as the CFP.
Financial advisors can further establish their credibility by getting a certification. Certifications are not required but are encouraged by financial advisory firms.
The most popular certification is the Certified Financial Planner (CFP). This test is issued by the Certified Financial Planner Board of Standards Inc. and tests advisors on their ability and aptitude to have a comprehensive holistic approach to financial planning. In addition to the exam, the certification also requires coursework and several years of working experience.
The CFP Board also has a strict code of ethics and a professional responsibility standard that lets clients know that anyone who maintains the CFP mark is of high integrity.
There are many other designations available to financial advisors. The Chartered Financial Consultant (ChFC) is put out by the American College of Financial Services and offers a similar program as the CFP.
In addition to passing the certification exam, many of these certifications also require extensive coursework or work experience.
Financial advisors also need to have real-world experience. Interpersonal sales skills can help attract new clients and understand those clients' needs. If a new financial advisor has a hard time communicating and selling to prospects, there is no chance of success.
While it is possible to get hired straight out of college, most financial firms prefer to choose candidates with some professional experience. An internship in finance can help a new graduate get hired, and many advisors come into finance after a previous career in another industry.
Maintaining clients is similar to running a business, and many managers prefer candidates with sales experience. In addition, many of the certifications listed above include a work requirement.
The exact qualifications for a financial professional depend on what types of services they provide. Those who wish to recommend or sell certain products to their clients must pass the appropriate licensing test from FINRA, and may have to register with a state or federal securities regulator. Professional certifications such as a CFA, CFP, or ChFC can add an additional level of expertise. Those working in finance as accountants or lawyers also have to meet the licensing requirements for their own industry.
Financial regulators and certification bodies will keep disciplinary records for any financial advisor under their authority. For securities advisors, you also have the right to ask your firm about the background and work history of the person handling your account, as well as about the firm itself.
In addition to the mandatory licensing requirements for different types of financial professionals, there are also several voluntary certifications that can demonstrate expertise in different fields. Two highly sought-after qualifications are the Chartered Financial Analyst (CFA) and the Certified Financial Planner (CFP).
When choosing someone to help manage money, it is important to know that your financial advisor is someone you can trust. In addition to their educational and work background, there are several professional licenses and certifications that can help identify a qualified specialist.
A complete audiobook version of the Solomon test Prep Series 53 Study Guide is now available for the first time.
— Jeremy Solomon, President & Co-founder of Solomon test Prep
PORTLAND, OREGON, USA, September 28, 2022 /EINPresswire.com/ -- Solomon test Prep has just released its first Audiobook for the Series 53 exam. A word-for-word studying of the Solomon test Prep Series 53 Study Guide, 4th Edition, the Solomon Series 53 Audiobook gives customers increased flexibility in where and how they study for the Series 53 exam.
The Municipal Securities Principal Qualification Exam, or Series 53, was created by the Municipal Securities Rulemaking Board (MSRB), the self-regulatory organization that establishes rules for municipal securities dealers and municipal advisors. Passing the Series 53 test qualifies individuals to oversee the municipal fund securities activities of a securities firm or bank dealer, as well as supervise associates working in multiple capacities related to municipal securities.
Passing the Series 53 test requires candidates to know a lot about municipal securities, MSRB rules, customer accounts, municipal securities trading, recordkeeping, suitability, settlement and delivery, federal securities acts, SIPC, and more. Since the Solomon Series 53 Audiobook is a verbatim studying of the 4th edition of the Solomon Series 53 Study Guide, it is up-to-date and covers all the key test topics.
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Solomon test Prep has helped thousands of financial professionals pass their FINRA, MSRB, NASAA, and NFA securities licensing exams including the SIE and the Series 3, 6, 7, 14, 22, 24, 26, 27, 28, 50, 51, 52, 53, 54, 63, 65, 66, 79, 82, and 99. Solomon test Prep also offers Investment Adviser Continuing Education.
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