Avoid Workplace Litigation and Non-Compliance Fines: Conduct an HR Audit

Scheduled On : Thursday, February 20, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

It only takes one disgruntled employee to file a complaint of unfair labor practices to incite a full blown investigation by the IRS, DOL, EEOC, ect. These investigations can interrupt you business as well as be time-consuming and very expensive. Are you prepared? By conducting your own HR Audit, you may avoid litigation and non-compliance fines. An HR Audit can also provide an objective look at the company’s human resources policies, practices, procedures, programs, and strategies to help not only protect the company from litigation and fines; it can establish best practices, identify opportunities for improvement, and evaluate outsourcing options. HR Audits can ensure effective utilization of HR resources and improve customer service, which in turn can increase revenue.

HR Audits can help the company become more efficient as well as save money, reduce productivity time, and cut costs. HR Audits can also help companies avoid non-compliance fees and government audits/intervention, such as Wage and Hour, EEOC, Unemployment, Workers Compensation, Immigration Services, Lawyers, etc.

Areas Covered in the Session :

• What is an HR Audit
• When to Conduct an HR Audit
• Who should conduct the HR Audit
• How to Conduct an HR Audit
• Step-by-Step Sample Audit of Healthcare Company, Including Report Out and Action Plan

Who Will Benefit: 

This is a must attend training for everybody involved in HR Auditing, including: 

• Business Owners
• HR Managers
• HR Representatives
• HR Generalists
• HR Assistants
• Consultants
• Managers
• Supervisors

Speaker Profile

Vanessa G. Nelson, MSA, SPHR, CLRL is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain legal compliance, avoid workplace litigation, reduce costs, increase revenue and competitiveness.

Vanessa established Expert Human Resources in 2009, after observing companies' frustrations with complying with constantly changing employment laws as well as continually dealing with workplace litigations and fines. Vanessa realized that a lot of the litigious situations that businesses encountered could be avoided by their being proactive and implementing updated polices and applying them correctly. Vanessa also recognized that many companies could not afford a full-time HR person, or department, to assist in maintaining compliance with employment laws, as well as applying policies and practices correctly; therefore she established a "portable HR" to accommodate those businesses.

Vanessa is a results-oriented HR Consultant with a unique background in business management, spanning over 29 years at Hurley Medical Center and Sparrow Health Systems. Her expertise includes: HR audits, labor relations, employment laws, employee relations, workplace investigations, and policies and procedures. Additionally, Ms. Nelson has implemented processes to improve conflict management and employee relations; conducted harassment training to improve company efficiencies, worked with multiple unions to produce positive outcomes, and has recruited dozens of talented employees. She is mobile and able to quickly interpret and apply policies fairly and consistently.

Ms. Nelson received her Master of Science in Administration/Human Resources Management from Central Michigan University, and a Bachelor in Business Management from Northwood University. She holds the Certified Senior Professional in Human Resources (SPHR) credential from Human Resources Certification Institute, Certified Labor Relations Leader (CLRL) from Michigan State University, and is Six Sigma White Belt certified.

Vanessa has conducted multiple seminars including: Lawsuits Waiting to Happen, Human Resources and Employment Law Updates, How to Conduct Effective Investigations, and FMLA.

Compliance Update : How does FDA Evaluate The Regulated Drugs ?

The Food and Drug Administration’s Strategic Action Plan for Risk Communication is an initiative to tell consumers how the agency makes decisions on the safety and effectiveness of FDA-regulated products. This is the first in a series of articles about the data and methods—and their limitations—that FDA uses to determine whether products are safe for patients and consumers to use.

This is how the agency’s Center for Drug Evaluation and Research evaluates the safety and effectiveness of drugs.

The Regulation of Drugs
How the Facts Are Collected

• The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works and if it will be safe enough to be tested in humans. The company submits an Investigational New Drug Application (IND) for FDA’s review prior to testing in humans.
• The company performs a series of clinical trials in humans in three phases, which FDA monitors, to test if the drug is effective and safe.
• Next, the company sends its data from all these tests to FDA's Center for Drug Evaluation and Research (CDER) in a New Drug Application (NDA). A team of CDER physicians, statisticians, toxicologists, pharmacologists, chemists and other scientists review the data and proposed labeling.
• If this review establishes that a drug's benefits outweigh its known risks for its proposed use, the drug is approved for sale.
• After the drug is on the market, the FDA monitors its performance in a number of ways. One of those ways is the through MedWatch, the agency’s safety information and adverse event reporting program, which receives reports of suspected adverse reactions (side effects of medicines) from consumers, health care practitioners and pharmaceutical companies. And the agency has access to databases that collect information on prescription drug use and health outcomes. These data help FDA staff identify and understand side effects of medicines.
• If an unexpected drug-related health risk is detected, a Drug Safety Communication may be issued to consumers and healthcare professionals. A statement is added to the drug label about the new safety concern to ensure continued safe and effective use of the drug. Occasionally, approved drugs may be withdrawn from the market for serious safety risks if it is determined that the overall risks outweigh any benefits the drug may provide.

The Limitations of Safety Data

• FDA provides guidance to companies during the various phases of the human clinical trials. Even so, the number of people in a clinical trial of a new drug is usually small in comparison to the number of people who may take the drug if it reaches the market. This makes it difficult to detect rare side effects.
• Even though data from human trials are analyzed by a team of experts before a drug is approved, it can be impossible to anticipate all bad reactions—especially very rare safety risks—unless they had also happened with use of a similar drug.
• Complicating matters is the fact that after they are approved, drugs are often taken by sick people who are on other medications at the same time, making it difficult to predict how they will react to the drug. And the drug’s effect on the patient may change over the course of years.
• There are hundreds of thousands of adverse events reported via MedWatch each year, but this reporting system is voluntary and there are serious drug reactions that are never reported.
• Because the nation’s healthcare system is not integrated, there is no standard way to track the adverse effects of a medicine in any given health system or across different health systems. Health insurance databases can be helpful in this regard, but they are only accurate as long as a patient has the same job and is enrolled with the same insurance system since many people are insured through their employer. This limits FDA’s ability to monitor the safety of medications taken over many years.  However, FDA, through its Sentinel Initiative, is currently working to develop capabilities to use data from different health systems to better understand the safety of drugs in clinical practice.

Ultimately, FDA faces a balancing act in evaluating a new drug. If it’s good for one person or a small group, will it be good for the whole population?  Which safety risks are likely to be acceptable to patients who might take a drug and physicians who might prescribe it? Once a drug is marketed and new information about its safety becomes available, FDA must revisit these questions continually over the drug’s lifecycle.

In the end, no matter how much data are available, we often have to make a judgment call, weighing the known benefits against known risks and the potential—and possibly unknown—risks.

Source: FDA
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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

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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.

Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)

While using animal-derived material in medical device manufacturing, the role of animal derived-material in medical devices is well established. However, these materials may carry a risk of transmitting infectious disease when improperly collected, stored or manufactured. The guidance describes the information you should document at the manufacturing facility and include in any premarket submissions.

So what are the considerations when using Animal-Derived Materials ?

Control of Animal Tissue Collection

• It is recommended to collect and document the following information for animal tissue-derived materials that are used as either device components (e.g., pericardium, viscera, bone, hyaluronic acid, collagen) or manufacturing reagents (e.g., tissue culture media, enzymes)
• You may document this information by reference to other regulatory submissions (e.g., Master File, PMA, 510(k)) that contain this information. 
• Maintaining records of the test results for any tests described above for each lot of material at the manufacturing facility and submitted in regulatory documents when appropriate.

Manufacturing Controls for Animal Tissue Components

• It is recommended you collect and document the information listed below for all animal-derived materials (and facilities) used in device manufacture.
• When appropriate, you should also describe these results in regulatory submissions.
• In addition, you should demonstrate and validate manufacturing equipment cleaning, decontamination, and sterilization relative to the specific pathogen exposure, and document the results.

Sterilization

• It is recommended that you consider the extent to which processing and sterilization inactivate or remove the virus.
• Recommendations for validating viral inactivation methods are described as follows:

Virus Validation Studies

• Assess the processing methods and sterilization techniques
• Obtain Viral inactivation data by determining the amount of virus in the unprocessed source material
• Determining for both before and after exposure to production and sterilization processes.
• The results should demonstrate the sum of the log clearance of virus.
• The sum must be at least six logs greater than the concentration of virus anticipated in the unprocessed source material.

Source: FDA

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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.

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