Compliance Training Webinars for Regulated Industries

This Webinar, the first in a three-part series, focuses on the methodology behind performing gap assessments for Food Safety Management Systems. This includes GFSI standards, USDA-FSIS, FDA Food Code 2017, HACCP, Preventative Controls, and FSMA under the broad umbrella of Food Safety Management Systems. Impacted individuals include those looking to implement new programs and systems or upgrade existing systems against these requirements.

This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.

This training program will discuss the four classification of exempt employees permitted under the IRS code including executive, administrative, professional and outside sales. It will examine the salary level test and the salary basis test.

This session will explain how a hospital medical staff should deal with the practitioner who is disruptive of hospital operations. It will discuss disruptive practitioner policies a hospital should have in place and practical tips to correct or terminate the disruptive activity.

Using a mock scenario involving an employee’s complaint of harassment against her supervisor, this webinar will walk through the stages of planning and performing a workplace investigation. While going through these stages, we will discuss best practices in handling investigations such as how to address requests for confidentiality, how to prepare for questioning key witnesses, and how to document the investigation. This webinar will also touch on key practices to minimize the risk of retaliation against the employee or witnesses.

This webinar will present approaches to instrument calibration that are used by FBI, FDA and EPA in forensic and environmental analysis. It will emphasize the importance of calibration in obtaining accurate results in analysis of trace evidence, toxicological specimens and environmental samples.

This webinar will discuss ways to value your private company using easy to implement methods and tools that don’t require advanced training or resources. We will be covering areas and measures that will be key to raising capital among shareholders and other financiers.

This webinar discusses the main areas of impact that documentation can have on a business to ensure that all members of the management team understand the proper methods, the results that can be achieved, and the costly mistakes that can be prevented with good documentation practices.

This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.

MIPS Data Validation Audits started in June of 2019. The MIPS has a number of vulnerabilities related to its reporting requirements and associated complexities. This presentation will address potential vulnerabilities and provide specific recommendations that will help protect your practice from a negative audit.

This training program will discuss the critical steps of the 360 degree feedback process, keys to identifying an effective 360 degree feedback instrument, important information regarding the selection of raters, insights into effective debriefing and coaching after debriefing can help an individual make necessary and suggested behavior changes which positively improve performance and perception.

This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.

The emerging medical foods market in the United States is $1.3 billion annually with strong growth potential. As a distinct, FDA-regulated category, medical foods are gaining more widespread acceptance. However, they remain poorly understood by patients, pharmacists and physicians. This webinar will describe the regulatory pathway for approval, the definition of a medical food, examples of medical foods, and product development opportunities.

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

In this Quality Management webinar attendees will learn what their organizations must do to realize a condition in which "The health of every organization depends on every member (whatever his place) feeling that everything that happens to come to his notice relating to the welfare of the business is his own job" and what the culture played an enormous role in the success of the Ford Motor Company in the first part of the 20th century, and it can play a similarly decisive role today.

An SLA - which can be a legally binding formal or informal contract between two parties, must comply with operating norms, which describe how the process is governed, managed, and controlled. In this webinar we will provide you with critical information on SLA process.

This training program will detail what just happened with the adoption of the new Same Day ACH Rule and what will it do for the ACH payments network. It will also help identify the impact on financial institutions (ODFIs and RDFIs), including their originators.

This webinar will describe the basic principles of drug metabolism, with specific emphasis on the various metabolic pathways and mechanisms that commonly reduce drug exposure. With greater understanding of these mechanisms, drug hunters have a higher probability of designing drug candidates that are less susceptible to metabolic clearance and elimination. The webinar will also highlight drug metabolism issues such as reactive metabolites and drug-drug interactions (DDIs) due to inhibition or activation of cytochrome P450 (CYP) enzymes. Common mitigation strategies for metabolism-related issues will also be reviewed.

This webinar will provide you a thorough background into the FDA regulatory and EU control issue related to the specific device required to provide expert opinions.

This webinar will discuss the basics of product registration in Mexico, Brazil and Argentina such as Registration Timelines, documentation requirements and governmental processes.