Preparing Your Furnace for the Winter

Preparing Your Furnace for the Winter

Austin and surrounding areas, it’s almost winter. We know it may not feel like it, but its around the corner, we promise. The oncoming winter means preparing your home and yourself for the change in temperature. The heating, ventilation, and air conditioning (HVAC) unit inside your space should be at the forefront of your preparation. And during the colder months, maintenance and consistent checks of your unit’s furnace is essential. The furnace of any HVAC unit provides warm air flowing, keeping us nice and toasty while indoors. Heating repair and maintenance is very important. Keeping your furnace happy and efficient, ensures your own happiness and efficiency during the colder months ahead. Here are a few tips from us at Alamo Austin Air Conditioning & Heating:
1. Change those dirty filters once a month. Clogged filters can restrict air flow, both warm and cold – thus damaging your unit and reducing efficiency.
2. Set your thermostat. It may sound foolish, but you’d be surprised. Adjusting the settings of your thermostat could reduce your monthly bill and ensure a more efficient warmth.
3. Check your heating vents. Debris surrounding your heating vents obstructs the flow and circulation of warm air indoors. It also increases the risk of fire.
4. Inspect your burners. Ensure that your burners are clean and the surrounding is clear. A blockage of a burner can become quite dangerous, as it leads to an increase of carbon monoxide during start up.

 

Preparing Your Furnace for the Winter
Your Answer for Heating Repair
Need more help with preparing your furnace for winter? Don’t hesitate to give us a call. When it comes to heating repair, Alamo Austin Air Conditioning & Heating is here for you. As experts in the field of all things concerning heating and air conditioning, we’ve got you covered. For the past 11 years we have been providing Austin and surrounding areas with the best air conditioning and heating service. Preparing Your Furnace for the Winter

Praetorian Commercial Auto Insurance Company

Praetorian Commercial Auto Insurance Company

In June 2007, QBE Americas completed the acquisition of PFG (Praetorian Insurance Group), previously a subsidiary of Hanover Re. QBE is Australia’s largest insurance group, but operates in 38 countries worldwide and employs over 16,000 employees. The Praetorian Insurance Company has sold and sold various policies, but its main focus is on businesses including commercial cars. This acquisition complements QBE’s product diversity strategy in the U.S. Now working under the roof of QBE in America; Praetorian still maintains its commercial insurance traditions.

Praetorian Commercial Auto Insurance Company

Understanding Commercial Car Insurance

In many cases, auto auto and commercial auto policies are very similar. Personal auto policies can even provide enough coverage for some business use, and this is useful when you drive a vehicle for personal and commercial purposes. You need commercial car insurance when your vehicle is only for business-specific use. One of the biggest advantages is that commercial car insurance has higher liability limits. This is also necessary if your business involves the transport of special equipment, the transport of goods and people, and the unusual use of vehicles for the example of pickup trucks and sports vehicles.

Similar to private cars, the rules of commercial vehicle insurance vary from state to state. QBE has licenses to sell and cover car insurance in 50 states as well as Puerto Rico and the District of Columbia. Since the Praetorian Insurance Company works under the roof of QBE, the license also applies.

A brief overview of commercially available commercial car insurance products from Praetorian Insurance Company:

Capacity:

– Enlarge to $ 1 million

-Umbrella to $ 5 million

Current Portfolio:
-Business Auto

-Local Trucking

– Specialized Commercial

-Auto includes car rental or used car dealers

Business Options

-Business Auto

-Artisan contractors’ auto business

Special transportation special

-Local distance, 50 miles

Coverage for commercial cars is more or less the same as private vehicles. The difference is within limits. The Preetorian Insurance Company offers new options up to $ 1 million and an umbrella option of $ 5 million. The amount should be enough to cover damages or liability issues if your business gets to the middle of a lawsuit as a result of a car accident.

Part of the personal auto does provide coverage even though the vehicle is for business purposes. However, it will not result in the same amount of financial protection as you can get from a commercial car policy. Imagine a situation when you drive a pickup truck to deliver the goods to the customer. In the middle of the road, you deflect your own van carrying several passengers. In such circumstances, the driver and passenger of the van will not sue you as well as your company. Your personal insurance policy provides financial protection and pays for the claim, but will not defend or pay compensation on behalf of your business. It is normal for drivers and passengers to collect compensation for vehicle damage and injury from you and your business. The Praetorian Insurance Company offers the right protection for such circumstances. Type of Coverage

The scope of the Commercial Commercial Vehicle Company’s Commercial Vehicle Policy may be narrow or broad depending on your choice. Insurance companies provide various policies for example trucks, special transportation, or wider auto business options. In a simple way, the options are as follows:

1-Vehicles as business property 2-Vehicles your company owns, leases, or leases 3-Vehicles for business purposes

Most companies will choose the third option because protection covers all vehicles, including those owned and owned by your own business, provided for business. Coverage even provides liability protection when employees or employers drive private vehicles for business. While the scope is different, the basic type of coverage is the same. The Commercial Auto Policy of the Praetorian Insurance Company still includes three significant safeguards including Responsibility, Physical Damage, and Optional Coverage.

-Liability Insurance: includes financial protection for property damage, bodily injury, and even accidental deaths where you or your employees are guilty. The scope also provides legal defense. The amount of protection to the extent of the policy. Praetorian Commercial Auto Insurance Company

-Physical Damage: This is a combination of Comprehensive and Collision coverage. It protects the damage of the vehicle whether the damage caused by accident or not. Risks include floods, vandalism, theft, or falling objects. Praetorian Commercial Auto Insurance Company

Home Improvements Offers Window Furnishing Solutions to Melbourne

Home Improvements Offers Window Furnishing Solutions to Melbourne

Blinds Melbourne – We Manufacture, Offer, Install and Consult on Window Blinds, Outdoor Blinds, Curtains and Windows Plantation for clients in Melbourne and western suburbs. We are specialized in Roller & Roman Blinds, Plantation Shutters, Melbourne Curtains and outdoor blinds. We can supply and install all kinds of curtains, awnings and window coverings. Let us come to you! We offer free consultation at home.
We provide quality Blinds products and best workmanship. Our showroom is based at the junction of the hopper. We are proud to provide the best quality blinds in the western suburbs of Melbourne and throughout Melbourne for our valued clients. We invite you to our showroom anytime where we will help you with color and design whether it is for your home or office. Styline-style homes throughout Melbourne include the intersection of Hoppers, Werribee, Point Cook, Wyndham vale, Williams Landing, Truganina, Tarnit, Laverton, Altona, Sunshine, Footscray, Maidstone, Maibyrnong, Deer Park, Newport and other western suburbs.

Home Improvements Offers Window Furnishing Solutions to Melbourne

We have a wide range of traditional Roman blinds and Roller roman blinds. They are available in different colors and sizes and like all our products can be customized to any requirement. Outdoor Blinds Melbourne is for a modern and comfortable home, with fabric panels and functional operating systems, this is the perfect choice that brings the softness to the room. In addition, we can customize it for chain withdrawal operations as well as cable locks. Roller Blinds are designed for heat and light control; This is a very popular modern blind that is suitable for all homes. Our spacious color, finish, and cloth are easy to use and are one of the most practical window shutters available. These Roller Blinds can enrich almost any home including contemporary, classic and contemporary styles.

Other ranges Include:

The zebra curtain, which is the main combination of roller blinds and venetian blinds, is easy to operate with optimal amount of sunlight entering the room.

Slide Panel is suitable for sliding windows, doors and even room dividers. Open and close, the glide panel performs neatly to produce great light control and high privacy. Overall, they offer simple yet natural decorations to your home.

Venetian blinds offer an elegant look for formal and relaxing bedrooms with adjustable sunlight angles entering the room. Wood venetian blinds suitable for work space and family room. Plastic and aluminum venetian blinds are available and are more suitable for bathroom and kitchen area. Home Improvements Offers Window Furnishing Solutions to Melbourne

Learn More about the Tonsil and Tonsil Stone

Learn More about the Tonsil and Tonsil Stone

Lymph nodes located on both sides of the back of the throat are called tonsils. The basic role of the tonsils is to act as a defense mechanism against infection. However, when they are infected, a condition known as Tonsillitis occurs. This can happen to children as well as adults of different age groups. The tonsils stop various types of bacteria and viruses entering the body through the mouth. And because of this they are also the most vulnerable to infections from outside attackers. Tonsillitis or tonsillitis can be caused by viruses from the common cold or bacteria from a sore throat. Learn More about the Tonsil and Tonsil Stone
Each tonsil is a network of holes or cryptography that stores cells that help in the fight against infection. Tonsils have the power to protect the body against various gastrointestinal infections and respiratory infections. Tonsillitis caused by the virus is contagious and remains for a week or ten days but bacterial-induced tonsillitis can last for two weeks. At TonsilStoneRemoval.org, one can find detailed information about tonsillitis, how it causes, precautions to take, symptoms to look for, natural treatments, transfers, diet, and so on. Often, tonsillitis can be handled at home with natural remedies and by eating and drinking warm fluids. Warm tea or broth can do the trick. A person can continue to rinse with warm salty water to relieve pain. They can also use throat throat to relieve pain.

Learn More about the Tonsil and Tonsil Stone

This site offers simple home remedies that can be used to treat tonsil stones. Grape seed extract, hydrogen peroxide, mouthwash, supplements, antibiotics, baking soda, vinegar, etc. are some of the ingredients that are helpful in treating the condition. There is a detailed explanation of how each and every method can be applied to get rid of tonsils. The site also refers to some supplements that have a positive effect on the condition. During these conditions, it is important to follow good oral practices such as brushing twice a day, using mouthwash, flossing, rinsing with salt water, using tongue scraper to clear the tongue, and others. This practice will help get rid of the condition quickly Learn More about the Tonsil and Tonsil Stone

Impact of FCO Travel Advice for your Insurance

Impact of FCO Travel Advice for your Insurance

Today’s journey can almost be described as science. Where many ordinary people think romantic about being careful of the wind and fearlessly embark on adventures with the unknown, we now have to sprinkle those impulsive impulses with careful doses and healthy common sense.
Thank goodness you do not have to pack a crystal ball in your suitcase to ‘get to know’. The miracle of modern technology will give you all the information you need. While traveling to some of the few rare hidden gems in the world such as the Middle East, travel insurance is a must, and it is best to read all the prints well.

Impact of FCO Travel Advice for your Insurance

Play by rules

The world is still, most definitely, a beautiful oyster, full of enormous experience and curiosity. Many travelers feel attracted to less standard goals in pursuit of a truly authentic experience. Since many of these places are not considered ‘typical tourist destinations’, their landscape, culture and way of life are all untouched by the modern western world.

However, when visiting these countries, it is even more important to examine their laws, regulations, and customs before traveling to ensure your own safety and to respect your host. For example, during a visit to the Middle East, travel insurance is an absolute must but so also recognize and respect local traditions in terms of dress, behavior and behavior.

Feasibility test Impact of FCO Travel Advice for your Insurance

Once you’ve researched your proposed goal, it’s time to read all the nice prints on your travel insurance. Should often refer to the FCO website (Foreign and Commonwealth Office) to get the latest report on the physical and political status of any destination country. Fortunately, these updates are easily accessible by computers and phones these days, so stay alert and alert before and during your visit can be second nature.

Also, know that the travel insurance industry, with your best interests, also monitors and follows all recommended FCO travel guides. So, if the FCO says ‘do not go’, you will not be able to afford a decent and comprehensive travel insurance for that purpose.

hot spot

If your destination is in the Middle East, travel insurance may be very expensive and may exclude certain geographical areas of your plan. For example, currently the FCO has advised against all trips to Yemen. Although beaches and landscaping such as in Yemen, civil conflict and terrorist attacks in the country have marked them as an official ‘no-go’ zone. FCO even went so far as to suggest all the foreigners to leave as soon as possible. As a result, no matter how much you decide to spend your Christmas on one of the idyllic beaches in Yemen, you will not be able to buy travel insurance, and it may be difficult to find travel options to the country.

Another suggestion of FCO is more precise and detailed. If you travel to Jordan in the Middle East, travel insurance may be available but may have geographic limits for coverage within the country. FCO is very cautious when visiting Jordan in general, but raises their warning for an area 3 km from the rest of Syria. The potential for wild mortars, small arms fire and terrorist attacks have increased in recent months and pose significant risks to residents and visitors.

Stay alert

FCO is an excellent source of up-to-date information on the political and geographic status of any destination. Most travelers prefer not to put themselves at risk when traveling, especially when traveling for pleasure. The FCO monitors the pulse of world conflict so that travelers can make wise decisions about their safety. Unfortunately, until there is political unrest and violence in the Middle East, travel insurance will remain high or may not be available. The beauty of these countries must wait to be discovered.

Tip for reconciliation with your wife

Tip for reconciliation with your wife

Many are having problems in their marriage and most of the time, people believe that the easiest way to get rid of this problem is to get a divorce. They believe that they have tried everything to do their wedding work again, but in fact they are not even looking for professional relationship assistance. It’s better to settle this relationship problem early on, because they love snowballing downhill and in time they can become bigger and bigger, making them almost too big to stop. Tip for reconciliation with your wife
When you observe that your wife is not satisfied, also when you have to start acting. The first and foremost thing you should do is communicate with your wife. This is the key to any successful relationship. Generally it is known that men are not so involved in communication, and this is a big mistake that makes their wives stop having the same feelings towards them as it was at first. Take your wife to dinner to a good restaurant or prepare a romantic dinner at home and talk to her. To save your marriage, be obliged to sit down and talk with your wife, no matter how long the discussion will last. You should discuss about the things that bother him and the reason why he wants to end the marriage. Tip for reconciliation with your wife

It is advisable to think about your own actions as well, as you may have done some things that really bother her even without realizing it. It may be difficult for a man to be reflective, thinking that you never made a mistake. However, if you ask any woman, this is definitely not true. Men should think about their actions and even ask their wives if such actions are the reason to experience problems in their marriage. It is advisable to try to correct the error as this will be an important step in saving the marriage.

However, if none of these solutions prove to be efficient, and you still want to save your marriage, because the woman you marry is The One, you should seek a relationship coach. Many people avoid going to relationship counselors, thinking that it is embarrassing, while others argue that if they do not manage to save their own marriage, a foreigner will certainly not succeed. However, many things are not thought of many people. If the trainer has a background in psychology and extensive experience in the domain, it is most likely to help you and your wife reconnect and rekindle the fire between the two of you. All you have to do is look for a professional and experienced relationship coach, because in this way you can be sure that the result is what you expect.

Being on the verge of divorce is definitely something nobody wants to experience. This is the reason why specialists suggest communicating with couples as often as possible and discussing matters and actions that may affect the quality of the relationship. Tip for reconciliation with your wife

Itchy Male Organ and Crabs: Shave or No Shave

Itchy Male Organ and Crabs: Shave or No Shave

Male organ health can help reduce the chance of getting crabs. But even so, accidents can happen, and a man must be prepared to know how to deal with this unwanted visitor.
So what is crab? Itchy Male Organ and Crabs: Shave or No Shave

Most adults can remember the “flea-bug” in their school, an incident where a child brings a hair tick to school, spreading from one student to the next. Crabs are associated with head lice, but fortunately it is not as easy as spreading.

Called crabs because of crabs like their looks, they’re tiny – usually less than a tenth of an inch. They are parasites that usually live in the male organ region, although sometimes can be found in other hairy parts, such as the armpit or chest. These small insects are harmless in the sense that they do not spread the disease, but once they get into the skin and start eating, they produce a hard push to resist scratches.

Most of the time, crabs are passed through skin-on-skin contact while engaging in sensual activity; More rarely, they can be caught from bed sheets or towels of infected people. Because ticks tend to gather in member’s hair and not on bead stems, wearing a rubber protective device is usually ineffective in preventing crabs from spreading. Itchy Male Organ and Crabs: Shave or No Shave

Shaving

Because ticks tend to make their homes in areas of hair members, it is often assumed that shaving areas of male organs is a good way to rid the body of these pests. The theory is that often the shave itself will get rid of the fleas, and the absence of warm and furry places to hide will make it easier to find and remove the remaining attackers.

But that is not the correct assumption. While it’s true that a razor can get rid of some of these crabs, it only captures a fraction of that amount. Many more are left in the skin, and because the color is so small, it’s hard to find it with the naked eye.

So, does that mean a man should not shave? Not all. While shaving maturity may not cure the itchy male organs caused by crabs, it makes the area more unfriendly and also makes it easier for doctors to recognize them with magnifying lenses. In addition, the absence of thick skirt makes hair easier to apply products that can help get rid of pests.

After being shaved

Once the area has been shaved, it is easier to receive a drug that can kill crabs. Although there is a free drug that works well, you should first check with your doctor first to determine the most effective action to take.

Crabs are more annoying than others, but an itchy male organ can make a man shy and become bad because of his self-esteem. The drive to scratch can be reduced through regular use of superior male organ health creme (health professionals recommend Man1 Man Oil, which is clinically proven to be mild and safe for the skin). The skin of well hydrated male members tends to not require itching, so use crème with excellent moisturizing combinations (such as Shea butter and vitamin E) is highly recommended. In addition, make sure the creme is equipped to keep skin healthy overall maturity either; creme with alpha lipoic acid, powerful antioxidants that fight free radicals and resultant oxidative stress, can be very beneficial.

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There are many things that come with having a male organ, and unfortunately the occasional prospect of maturity that itch is one of them. Although having to scratch occasionally is not a big deal, it can be annoying, annoying and downright embarrassing when the itch becomes chronic – as it usually happens when the itchy cause is the dreaded crab. Taking into account the health concerns of male organs can help reduce the possibility of catching crabs. But even so, accidents can happen, and a man must be prepared to know how to deal with this unwanted visitor. Itchy Male Organ and Crabs: Shave or No Shave

So what is crab?

Most adults can remember the “flea-bug” in their school, an incident where a child brings a hair tick to school, spreading from one student to the next. Crabs are associated with head lice, but fortunately it is not as easy as spreading.

Called crabs because of crabs like their looks, they’re tiny – usually less than a tenth of an inch. They are parasites that usually live in the male organ region, although sometimes can be found in other hairy parts, such as the armpit or chest. These small insects are harmless in the sense that they do not spread the disease, but so mer

Commitment in the New Year, Not Difficult To Achieve Simple Rules

Commitment in the New Year, Not Difficult To Achieve Simple Rules

If one of your resolutions for the New Year is finding, or improving, the relationship you can make, it’s probably easier than you think. Commitment in the new year, or at any time, is not too difficult to achieve but you must follow some simple rules if you want to succeed.
Commitment in the new year will arrive at one fundamental point: are you absolutely sure that you want to make a commitment with a particular person?

Obviously, I know. But do you know how many people really ignore this simple rule? So many people think they want to be in a committed relationship, but in many cases it’s not about them and what they want, it’s more about what they think they should do. Commitment in the New Year, Not Difficult To Achieve Simple Rules

For example, when we arrive at a certain age we are under pressure to “settle down”. Pressures can sometimes come from our parents, our friends and even the public.

It is easy to confuse the pressure with our own wants and needs. Often people will lie to themselves and convince themselves that yes, they really want to be calm when in fact they do not want to but they feel guilty and feel doing something wrong.

When you do something, quite a lot of things, just because you think you should, even if you do not really want it, you just make yourself fail.

Before you begin down the path of “commitment”, stop and take a deep breath and make sure it’s really what you want to do. Commitment in the New Year, Not Difficult To Achieve Simple Rules

While compromise is an essential ingredient for any successful relationship, whether romantic or not, it is not something that needs to be compromised.

If you really are not where you want to be in a committed relationship but you follow it because that’s what your spouse wants or you feel pressured to do, you will fail.

A committed relationship can be a challenge in the best of times and if it is something you do not even want, it will be much harder to keep that promise and truly committed to that relationship. Commitment in the New Year, Not Difficult To Achieve Simple Rules

Another thing to keep in mind is that too many people will tell you that “relationships need work” or “relationships are difficult”. How many times have you heard from someone?

Well, I think it’s wrong. I have been in good and bad relationships and I can tell you that when you are in a good relationship, there really is no job at all. There is little need for compromise because both of you will see many things.

If you need a compromise, it’s a real compromise where you both give a little. Not what people call compromise is when only one person does the giving and the other does most of the taking.

Make sure before you promise to bring the relationship to the next level that you really are in a relationship with the best person for you.

Increasing your commitment in the new year can help you and your spouse discover true happiness and deepen the bond between you. Do not go in there blindly or you may really regret it with time.

Sensual Toys for Him and Her: Thank God for Technology

Sensual Toys for Him and Her: Thank God for Technology

Technology has made some exciting strides in the realm of sensual toys. Toys are not just for women; there is plenty of options out there for “pocket pussy” (not that there’s anything wrong with that old stand-by!). Frequent seed release is believed to be a component of good man’s body health, and self-pleasuring is a great way for a man to get to know his body. Not to mention, it’s one of the more enjoyable activities in the world. Learning about the amazing options out there can help a man expand his self-pleasuring horizons, and his lady’s, too. Sensual Toys for Him and Her: Thank God for Technology
Autoblow 2

As the name suggests, the Autoblow 2 is designed to simulate the feeling of oral sensual activity. It has a sleeve in which the male organ is inserted, and two rows of rollers that move up and down the organ via motor power. The sleeve is easy to wash. It is recommended that use a water-based lube with the toy. The Autoblow 2 runs upwards of $ 159.00, but for a hands-free solo-based simulated blow job, that’s not likely too steep for many men.

Lovely

The Lovely is a wearable device for the male organ that serves many functions. First, it vibrates, which is a pleasurable experience whether with a partner or on one’s own. But where the real technology comes in is with the Lovely App; the device records data, including thrusting G-force, speed and sensual positions, and sends this information to an app that can use to analyze their performance. Partners can participate in this process as well. Along with vibrating and giving performance information, the app makes suggestions for new positions to try. Finally, it counts how many calories a man burns during his romp.

Lovely’s creators launched an IndieGoGo campaign to fund the product, but the campaign fell short. However, the creators are continuing to gather investors, so should keep their eyes out for this fun device.

OhMiBod blueMotion

This funky toy allows couples to get frisky in public, adding a whole new level to pre-play. The man uses an Android or iPhone app to control the vibrator from up to 30 feet away, and the toy can be worn by a woman wherever she goes (it comes with a thong that contains a pocket for the vibrator). This opens up some options for couples with a naughty streak – the man can surprise the woman with a pulse here or there while they’re out on the town, or send her on a prolonged journey to release unexpectedly from another room. Discuss boundaries with partners. Sensual Toys for Him and Her: Thank God for Technology

These are but a few of the many options out there for playful men, and, with ever-advancing technology, the market can only be expected to grow more innovative and titillating.

As men incorporate new toys into the mix, they may find themselves spending a bit more time than before with their members. It’s important to practice good hygiene and take extra care of the skin to prevent chafing and dryness.

Along with thoroughly washing all sensual toys with mild cleanser and using plenty of lube, men may also want to invest in a male organ health crème (health professionals recommend Man1 Man Oil). A crème with Shea butter and vitamin E provides superior moisture to protect skin from the frictions of the day and night, helping keep it soft, smooth and ready for the next romp, be it with a hand, toy or partner. Man1 Man Oil also contains acetyl L-carnitine, which has neuroprotective properties; this is important, as frequent and / or rough handling can lead to a deadening of manhood nerves and therefore of pleasure over time. Keep the male organ in top form with a health crème to ensure that sensual toys stay enjoyable for the long-haul. Sensual Toys for Him and Her: Thank God for Technology

Complaint Handling, Adverse Event Reporting, and Recalls

Complaint Handling, Adverse Event Reporting, and Recalls

Medical device makers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, ISO 13485: 2016, recognizes this fact. Different requirements of each regulatory system require manufacturers to identify their roles, as well as regulatory requirements for the role, and then incorporate them into their Quality Management System. Various jurisdictions, however, address the problem of post-market devices in various ways. Complaint management, reporting of adverse events and withdrawals are three interrelated and interrelated processes that need to enter SMM. Corrective action and design changes, which support the QMS process; also need to complete these three processes. And then, the regulatory requirements, which typically involve areas such as recording and reporting, are also entered. Course on how to implement an integrated QMS GlobalCompliancePanel, a leading professional training provider for all regulatory compliance areas, organizes excellently educational and valuable learning sessions about these primary and secondary SMM processes and how they need to be understood and implemented in conjunction with US, EU, and Canada. Dan O’Leary, president of Ombu Enterprises, LLC, a company that offers training and implementation in Operational Excellence, which focuses on analytical skills and systems approach to operations management, will be the director of this two-day seminar. And brings more than 30 years of experience in the field of quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical laboratories. Want to benefit from Dan’s rich experience and want to understand how to implement integrated SMM where various aspects of  Complaint Handling, Adverse Event Reporting, and Recalls  complaints, reporting and adverse withdrawal are built? Please sign up for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900960SEMINAR?Article-SEO. The seminar was approved by RAPS eligible for 12 credits against RAC recertification after completion. Alignment with FDA FDA The degree of alignment with the requirements of the FDA Quality Management System (QMS) is an interesting one from the final version of the ISO 13485: 2016 standard, which is now available. The alignment rate set at 2016 versions in 13485 may be much higher than the previous version of 2003; However, there are still some points where it deviates from the FDA QMS. Companies that must comply with these standards should keep this in mind. Now after ISO 13485: 2016, the Medical Single Audit System (MDSAP), and the new EU Medical Device Regulations have been introduced; companies need to update their QMS and integrate all elements if their implementation is to be effective and appropriate. In this two-day session, Dan will provide the tools the participants need for this. The agenda of this learning session is as follows: • Regulatory Structure? FDA QSR? ISO 13485: 2016 and regional variants? ISO 14971: 2007 and regional variants? Implementing MDSAP? EU Medical Device Regulations • Maintenance? Identification of problems ? Serving data analysis? Feedback to the grievance process • Complaint Identify complaints? Evaluate a complaint? Investigating a complaint? Complaint data analysis? Put it into a corrective action process? Feedback to risk management process • Corrective Action? Develop the process? Analyze product and process information? Determine the next action? Put it into the design process? Feedback to risk management process • Design and Design Change? Determining the need for design changes? Documenting the design changes? Design change verification and validation? Feedback to the risk management process? Input into the pre-market delivery process • Risk Management? ISO 14971: 2007 and regional variants? Entering post market information • Updating Pre-Market Submissions? US – Guide 510 (k)? EU – Technical files and design documents? Canada – License change • Bad Event Reporting? US – MDR? EU Alert Reports? Canada – Mandatory Obligatory Reporting • Remember? US – Corrections and Removals? EU – Corrective Action of Field Safety? Canada – Remember Complaint Handling, Adverse Event Reporting, and Recalls