Compliance Training Webinars for Regulated Industries

This technical writing training program will offer attendees an understanding of how the reporting process supports products in the medical device industry. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

This course will focus on Risk Management in the Pharmaceutical and BioTech space. It will cover Risk Management Programs and also managing general regulatory risks in the drug development process.

Join Elaine Eisenbeisz as she shows you how to use data to estimate a standard curve, how to perform computations for absolute and relative quantification. She will also present a few decision-making criteria and statistical tests that can be used with qPCR data.

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, which is critical in order to be able to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project that you may undertake, and the importance of the sequence of steps will also be covered, to ensure you are able to comply with FDA expectations.

This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.

In this food safety webinar attendees will learn the broad overview of the Safe Food for Canadians Regulation (SFCR) standard to process, import or export foods for Canada covered with background, new revisions, enhanced regulations, tools and portal for compliance.

This webinar is prepared to explore how foods are regulated in Canada. We need to learn those laws in order to understand how to best manage compliance. The broad goal by the end of the webinar is to gain a better understanding of how foods are regulated in Canada.

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.