How to withstand an FDA audit of your facilities: A primer for clinical sites, manufacturing facilities and labs

Scheduled On : Monday, February 10, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

 REGISTER NOW !

Description : 

In this webinar, you will learn how convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.

The FDA reserves the right to audit any facility involved in manufacture, testing or development of food and drug products. These include not only drugs and biologics but also medical devices, diagnostic kits, dietary supplements, veterinary products, and animal and clinical testing facilities. FDA audits are an essential part of assuring compliance with the current regulations. Although most FDA audits are preannounced, FDA does conduct unannounced inspections of facilities that it suspects of noncompliance. FDA conducts thousands of audits each year of facilities World-wide to assure that products and services available to the American public are of acceptable quality.

FDA audits are very detailed and systemic reviews of a given facility that could span over several days, involve most personnel working at the facility under review, and if evidence of non-compliance is found, could lead to severe restrictions and/or penalties on the responsible parties. More often than not, facilities and personnel are ill-prepared and unaware of the dos and don’ts for an FDA audit and thus get into trouble for easily avoidable errors. Hence, it is very important that at all times FDA-regulated companies be aware of the regulations, logistics, and practical aspects of an FDA audit to be able to successfully withstand the same.

If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA or if you were last audited 4-6 years ago, if any product or service you offer has been in the news – positive or negative, or if you are getting ready to submit a clinical trial or marketing approval application, chances are you would get audited by the FDA in the near future. Although different facilities are subject to different regulations, FDA auditors follow some general guidelines that are common across all. We will discuss the general rules and specific case studies to highlight the common themes and differences across facilities subject to GCP, GMP or GLP regulations.

Areas Covered in the Session :

This seminar will discuss ways to be prepared for an FDA audit, conduct during an audit, and follow-up activities to an audit. Topics covered include:

• Types of FDA audits
• Key guidelines available from FDA
• GCP/GMP/GLP requirements
• Preparing for the inspection
• Why inspections are conducted and by what statutory authority?
• Reasons for FDA conducting an inspection
• What to expect from an audit?
• What is subject to FDA purview and what's off-limits?
• Preparing for an audit
• What you need to know and do
• Prepare for, during and even after the inspection
• Actions to be taken upon the investigator's arrival
• Logistics of the FDA audit
• Do’s and don’ts of an FDA audit
• Follow-up to an FDA audit
• What to do next?
• How to respond to findings and facilitating the documentation and remediation process
• How to reach Final Closure

Who Will Benefit: 

This webinar will provide valuable assistance to all personnel in: 

• Quality Assurance professionals
• Quality Control professionals
• Regulatory affairs / Compliance professionals
• Senior management executives (CEO, COO, CFO, etc)
• Manufacturing managers, supervisors & personnel 
• Clinical and Preclinical laboratory managers
• Clinical trial specialists
• Project Managers
• People investing in FDA-regulated product development projects

Speaker Profile

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

This holiday season, Lock up your medicines to protect children and teens

The holiday season brings guests of all ages into your home, so it’s an especially important time to make sure your medications are locked away safely in order to prevent accidental poisonings in children and misuse by teens. Hospitalizations and even deaths from medications meant for someone else are growing problems among kids and teens.

Children and teenagers can get into medications that can be dangerous and how to lock them up securely. Each year, thousands of children and teens are hospitalized because they've taken medications that have not been properly secured. 

A child may discover a pill box or a package of cold medicine on a bathroom counter, mistaking them for candies because of the attractive colors.

A teenager may take pills out of a medicine cabinet or a purse to experiment. Ever heard of "Pharm Parties" ? These are parties where in teens get together to share the prescribed medicines with their friends. Tragically, these scenarios are not uncommon, but they can be prevented.

Protect your loved ones this holiday season by locking away your prescription and over-the-counter medications before they wind up in the wrong hands. It’s a small step that can save a life.

For more Compliance updates and trainings, logon to Compliance Trainings

.

Improvements To The Medical Device Recalls Database

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) recently announced improvements to several public databases that will increase access to safety information on marketed medical devices. The improvements include adding new fields to the Medical Device Recalls database disclaimer icon and providing links to the recall database from FDA’s 510(k) Premarket Notification disclaimer icon and Premarket Approval (PMA) disclaimer icon  databases.

Specifically:

• The 510(k) and PMA databases will have a CDRH Recalls hyperlink at the bottom of each record if there are recalls associated with that medical device.
• The recalls database has been expanded to include recall status (whether or not the recall has been terminated), product classification (product code), premarket submission numbers associated with the recall (510(k)s and PMAs only), and the root cause of the recall as determined by the FDA. Also, the previously available field "Reason for Recall" has been renamed "Manufacturer Reason for Recall" to better clarify the source of the information.
• In addition to the new and renamed fields, two new links are available at the bottom of recall records. The first will search the Total Product Lifecycle (TPLC) database for additional information regarding other devices with the same product code as the recalled device. The other will search the premarket databases for other premarket submissions of this type of product from the same applicant. This will provide information about submissions cleared or approved after the recall.

For more Compliance updates and Trainings login to https://compliancetrainings.com

.

Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography

What is a nipple aspirate device ?

It is a type of pump used to collect fluid from a woman's breast. A nipple aspirate test can determine whether the fluid collected from the breast contains any abnormal cells.

Certain manufactures are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells.  The FDA is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.

Possible health consequences include false negative test results, indicating the absence of breast cancer when cancer exists, and false positive test results, indicating the presence of breast cancer when none exists.  False negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk of serious illness or death.  False positive results may lead to needless patient anxiety, along with unnecessary additional testing and treatment.

The FDA is alerting the public, including women and health care providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer.  The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.

The FDA, other public health agencies, and national medical and professional societies agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages.  These organizations include the American Cancer Society, the American College of Radiology, the Centers for Disease Control and Prevention, the National Cancer Institute, and the Society for Breast Imaging. The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique.

What Health Care Providers are recommended:

• Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis.

What Patients are recommended:

• Remember that a nipple aspirate test, such as Atossa Genetics Inc.'s Mammary Aspiration Specimen Cytology Test (MASCT) and/or ForeCYTE Breast Health Test systems, or the HALO Breast Pap Test, is not a substitute for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself for breast cancer screening or diagnosis.
• If you have had a nipple aspirate test as a stand-alone evaluation tool for screening and diagnosing breast cancer, you should request a mammogram from your health care provider to get accurate results.
• Undergo regular mammograms according to screening guidelines or as recommended by your health care provider.

For more Compliance updates and Trainings login to https://compliancetrainings.com

Compliance Update: FDA approves medical device to treat epilepsy

The U.S. Food and Drug Administration approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.

The RNS Stimulator consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.

Epilepsy produces seizures affecting varied mental and physical functions. Seizures happen when clusters of nerve cells in the brain signal abnormally, which may briefly alter a person's consciousness, movements or actions. According to the Epilepsy Foundation, epilepsy affects nearly 3 million people in the United States and is the third most common neurological disorder, after Alzheimer’s disease and stroke. Approximately 40 percent of people with epilepsy are severely affected and continue to have seizures despite treatment.

The FDA’s approval is supported by a three-month randomized control trial of 191 patients with drug-resistant epilepsy.

The study showed that by three months after the implanted device was turned on (active use) patients experienced a nearly 38 percent reduction in the average number of seizures per month, compared to an approximately 17 percent reduction in the average number of seizures per month in patients who had the implanted device turned off. At the end of three months, the median reduction in seizures, which reflects a more typical patient experience, was 34 percent with active use and about 19 percent with the device turned off. During the trial, 29 percent of patients with an active device experienced at least a 50 percent reduction in the overall number of seizures, compared to 27 percent for those with the implanted device turned off.

During a two-year follow-up phase (unblinded), data demonstrated a persistent reduction in seizure frequency.

Patients with RNS Stimulators cannot undergo magnetic resonance imaging (MRI) procedures, nor can they undergo diathermy procedures, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS). The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off.

The most frequent adverse events reported were implant site infection and premature battery depletion.

Source: FDA

For more updates and trainings on FDA regulated industries, visit Compliance Trainings

FDA slaps 'deadly' tag on Atossa's cancer Dx recall

The FDA has applied its most serious label to Atossa Genetics' ($ATOS) recall of a breast cancer diagnostic, warning that using the unapproved devices could lead women to forego treatment and increase their risk of serious injury and death.

Atossa voluntarily recalled the ForeCYTE Breast Health Test last month after a February FDA warning letter chided the company for marketing its system without agency clearance. Atossa billed its test as a tool to determine patients' cancer risk by screening small amounts of nipple aspirate fluid, but the company never secured the FDA's backing for those claims.

Now, the agency has applied a Class I label to the recall, warning that using ForeCYTE as a stand-in for mammography or other diagnostic procedures could put patients at serious risk. False positives could spur needless anxiety and unnecessary medical costs, the FDA said, while false negatives could lead to delayed diagnosis and treatment of breast cancer, increasing chances of death.

Atossa has said it's working with the FDA to get its banner product back on the market, but it may be difficult to reverse the damage, and the company's shares have fallen roughly 60% since October. The recall came amid Atossa's nationwide commercial scale-up for ForeCYTE, following partnerships with distribution giants McKesson and Thermo Fisher ($TMO) to spread the system around the country. The company believed its test had a chance to become as ubiquitous as the Pap smear, CEO Steven Quay said.

Atossa has said it hasn't heard of any adverse events tied to ForeCYTE, and the FDA is asking patients and physicians to report problems through its MedWatch platform.

Source: FDA

For more updates and trainings related to FDA, visit Compliance Trainings.

.