2018 FDA Inspection Policy & Best GMP Practices

$197$405

In FDA-regulated industry, it is imperative that firms should be well aware of and understand what laws and regulations apply for FDA-regulated medical and other products like food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics. The FDA conducts inspection to enforce these rules and regulations. This webinar is intended to discuss FDA … Continue reading 2018 FDA Inspection Policy & Best GMP Practices

The Federal False Claims Act(FCA) & The Anti-Kickback Statute(AKS): Is Your Organization at Risk ?

$197$419

Recent cases and/or enforcement actions involving the Federal Civil False Claims Act (FCA) raise serious concerns regarding compliance issues with hospital, physician practices and other healthcare entities. Recoveries under the FCA are at an all-time high, and the percentage of actions involving healthcare organizations has been increasing at exponential rates. Add to that, a substantial … Continue reading The Federal False Claims Act(FCA) & The Anti-Kickback Statute(AKS): Is Your Organization at Risk ?

Departing Employees and HIPAA: Terminating Staff Access

$197$405

Today, staffs in medical offices have access to a number of systems that may be used for the access and management of Protected Health Information.  There may be a patient management system that may or may not be integrated with an EHR, an e-mail system, access to file systems, access to government sites and health … Continue reading Departing Employees and HIPAA: Terminating Staff Access

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

$197$405

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance. The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built … Continue reading 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

Coding Vs. Auditing: Does It Boil Down To Medical Necessity?

$197$313

Coders are taught very strict guidance and rules of code selection look-up, proper order of selection, and linking codes correctly, but the art of abstracting medical necessity from the documentation is often-times not taught until one reaches the world of auditing. This creates problems in that coders typically assign the codes prior to claim submission … Continue reading Coding Vs. Auditing: Does It Boil Down To Medical Necessity?

FDA Dietary Supplement CGMP Regulations

$197$401

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the U.S, Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications … Continue reading FDA Dietary Supplement CGMP Regulations

Customs and Trade Partnership Against Terrorism (C-TPAT) Compliance

$197$405

The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP).  It is intended to improve the security of supply chains of private enterprises against the threat of terrorism. In this webinar, we will provide an overview of the Customs and Trade Partnership Against Terrorism … Continue reading Customs and Trade Partnership Against Terrorism (C-TPAT) Compliance

Legacy System Replacement for Computer Systems Regulated by FDA

$197$405

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance. The webinar will focus on the importance of carefully managing the replacement of a legacy system … Continue reading Legacy System Replacement for Computer Systems Regulated by FDA

OSHA Guidelines for Hospital Ergonomics

$197$401

Occupational Safety and Health Administration(OSHA) defines Ergonomics as the science of fitting the job to the worker. When there is mismatch between the physical requirements of the job and the physical capacity of the worker, work-related musculoskeletal disorders (MSDs) can result. Ergonomics is the practice of designing equipment and work tasks to conform to the … Continue reading OSHA Guidelines for Hospital Ergonomics

Marketing To Patients Via Texting & E-mail: HIPAA, TCPA, And CAN-SPAM Considerations

$197$409

Medical Offices have powerful new tools available to them for reaching out to their patients to describe products and services that patients could be interested in.  However, there are limitations on the use of Protected Health Information(PHI) for marketing purposes and limitations under other laws that limit contacting patients on their cell phones. As healthcare providers … Continue reading Marketing To Patients Via Texting & E-mail: HIPAA, TCPA, And CAN-SPAM Considerations

Food Safety, Security and Fraud: Are you ready?

$197$405

Since 2011 the entire U.S. food supply chain has had to face new challenges due to the signing of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) into law.  Since then, rules have been finalized and new challenges have arisen across the entire supply chain as companies try to understand food safety, … Continue reading Food Safety, Security and Fraud: Are you ready?

Certified Medical Compliance Officer (CMCO)

$2,095

Earn 32 CEUs from Practice Management Institute The evolution of health care is changing the way we handle patient records, write prescriptions, bill for services, and work with physicians, hospitals and suppliers. As if all of this were not stressful enough, the Office of the Inspector General (OIG) is watching and commanding total compliance with … Continue reading Certified Medical Compliance Officer (CMCO)

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