Compliance Training Webinars for Regulated Industries

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.

This webinar compares the EU and FDA regulatory protocols to help individuals involved in manufacturing, customer service, quality assurance roles to streamline their understanding of the rapid and ongoing regulatory changes being adopted by all medical device regulatory bodies where manufacturers sell and manufacture their devices.

This webinar will review the compliance issues that most greatly impact on your practice such as the 2-midnight rule, the NOTICE Act, HINNs, and many others. It will help you to identify where you may have compliance practice gaps as well as how to fix them.

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

This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach

This webinar training on stress testing in financial institutions will depict scenarios, pitfalls to be avoided, and discuss how the choice of the right scenarios can provide good insight into strategic management of a financial institution.

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

In this 60-minute session, the trainer will cover all the recently approved changes and details for returning an unauthorized transaction, including when to use a R10 or an R11 Return Reason Code. Examples used throughout the session will outline these changes, describe their effect on you as a participant in the ACH network, whether you are an RDFI or an ODFI.