Compliance Training Webinars for Regulated Industries

This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.

Attend this webinar to learn how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order 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.

This course will describe the Medicare Coverage Analysis (MCA) process and the revenue cycle’s uses for this document. The course will describe the creation of the MCA and the multiple uses for this document.

In this Quality Management webinar attendees will learn the traditional attribute sampling plans required for very large samples & narrow limit gauging for smaller samples that relies on tightened acceptance limits to assess the quality of a sample which can reduce the required sample size and cost of inspection.

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

What has been the sum impact of this dizzying array of action for U.S. businesses and the American economy? What can corporate America expect in the final 18 months of his first Administration? What are his chances for re-election? And If he wins again, what can we anticipate in term two? In this webinar, get perspectives about these and more.

Attend this seminar to learn how to get the results your organization expects applying fundamental approaches to tackle special assignments and integrate your work into a large project, you manage productively and systematically.

This Webinar, the second in a three-part series, focuses on the methodology behind performing Implementations of 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.

QA groups in the pre-clinical space need to be the driver of change and improvement in their organization. In the coming decade the reliance on management to be a driver of change is no longer a held value. Senior management is looking to QA to be to set the tone for the organization and be the champion of the changing regulatory environment.

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

This fraud training program will focus on understanding the fraud problem and what propels employees to commit fraud. The course will also offer essential fraud detection tools and techniques and highlight best practices for developing and implementing anti-fraud controls.

This webinar will explain how to perform anti-fraud audits in the purchasing/accounts payable cycle. It will discuss the use of Audit Control Language (ACL) and how this tool and other tools like it (IDEA) are helpful in the analysis of accounts payable and purchasing data.

This webinar will cover how to write a paper. Guidelines on framing a paper, journal selection and tips for publishable paper will be provided.

This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.

This webinar will provide an overview of how to prepare effective responses to warning letters that FDA will consider acceptable. It will help you know how to negotiate with FDA to effectively close Warning Letters.

This training will provide an effective process on how to handle criminal background screening whether you are in a ban the box state with strict regulations or is you follow the Equal Employment Opportunity Commission (EEOC) guidance on how to avoid discrimination when rejecting an employee with criminal background convictions.

Firms must develop criteria to determine whether they meet FDA’s qualification requirements to participate in this expedited 510(k) clearance process. This program requires a firm to develop and implement a rigorous initial and ongoing quality assurance program. Attend this webinar to learn how to.

Attend this webinar the principal elements that an OSHA Compliance Officer will look for during an inspection. Most of these elements are functional, operational, physical, such as machine guards, fire extinguishers, safety gear, PPE, etc. OSHA’s required ‘written programs’ in key safety disciplines, such as PPE, Lock Out-Tag Out; Silica Dust; Respirators; Hazard Communication/Globally Harmonized Standard; etc. will be discussed. It will explore the administrative side to the simulated inspection, such as your organization’s written safety & health program.

Structure Alerts, also known as toxicophores, are classes of chemicals, functional groups or substructures that, when present in drugs or drug candidates, have been linked to preclinical toxicity and/or adverse drug reactions in humans. This webinar will define and describe many of those structure alerts and outline the mechanisms that have been associated with their toxicity. Mitigation strategies will also be discussed.

This webinar will present and apply FBI, FDA and EPA approved methods for the determination of limits of detection (LOD) and limits of quantitation (LOQ) in chemical forensic and environmental analysis. These methods apply to most analytical techniques including gas and liquid chromatography, mass spectrometry, and elemental and molecular spectroscopy and can be used when analyzing blood, urine, food, or trace evidence for the presence of toxic chemicals or drugs.