Upcoming Events in Baltimore Maryland
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2-day In-person Seminar on "Effective Complaint Handling, Medical Device Reporting and Recalls" in Baltimore
- An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analysed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labelling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing.
Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.
The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up.
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.
Annual Rim Source Motorsports Charity Car Show
- Come join us for Rim Source Motorsports' Annual Charity Car Show to benefit Toys for Tots. Sunday, 9:00 am - 2:00 pm. 2ft Trophies awarded to 30 "Best Judged Scored Vehicles". 3ft. trophies for 5 "Special Best Awards" (Best Engine, Best Interior, Best Paint, Best Rims, and Best Awards Display) 4ft trophy, plus $100.00, for Best In Show. Entry Fee: $20.00 preregistration, $25.00 day of the show. For more information or to register for the event contact Shawn Chambers or Rim Source @ (410) 675-4988.
Address: 4810 Belair Road Baltimore, MD , Baltimore, Maryland
Easterns Bayside Blues and Wine Festival
- Blues and Wine Festival along Waterfront Overlooking the Chesapeake Bay.
Unlimited Wine Tasting from Maryland Wineries 1pm-7pm.
Unlimited Blues Music from 1pm-11pm.
Address: 2330 Seneca Road, Baltimore, MD 21239 , Baltimore, Maryland
MCA & Security Square Mall's Annual Fall Best .vs. Best Custom Car & Bike Show
- This show is for Best .vs. Best for. We only have 45 spaces for cars and 10 for bikes. 1st come 1st to get registered for the show. Entrance fee is $35.00. Registration Time: All registered vehicles must be at mall by 8:00 am for vehicle set up. NO EXCEPTIONS Show Begins at 1:00 pm Cash/Trophies awarded at 4:00 pm.
Trophies Awarded to 20 Best Judged Vehicles People's choice voting manager/staff voting 20 (2 ft.) Trophies Awarded in the Competition 3 ft. Trophies for Best Chevy, Best Mopar, Best Import, Best Ford 3 ft. Trophies for Special Awards Best Interior, Best Rims, Best Engine, Best Paint, Best Awards Display 4 ft. Trophies Plus $75.00 for Best Show Car and Motorcycle 5 foot Trophy Security Mall People's Choice Pick.
Carpet Must be under wheels, you must have drip pans, you battery must be disconnected, and less than a half tank of gas. Vehicles will not be able to leave the mall until the mall is closed NO EXCEPTIONS A photo of your vehicle must be sent with you registration form. Send check or Money order to:
Address: Security Square Mall, 6901 Security Blvd. Baltimore, MD 21244 , Baltimore, Maryland