Compliance Training Webinars for Regulated Industries

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.

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

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.

This training program will answer questions related to IFRS financial statements and compare them to GAAP based statements using numbers from examples that come from every-day life. The course will also analyze the four key principles of IFRS and the cash flow statement, and discuss using financial statement notes to decode the numbers.

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll gain insights into the regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance.

This webinar distills learnings from more than 20 years spend providing guidance to biopharmaceutical companies and related stakeholders. You will learn how to find and evaluate branded and generic entry opportunities, how to anticipate changes in demand for drugs, and how to add value to your partnerships.

This webinar will identify elements critical to both the compliance and effectiveness of an On-the-Job Training (OJT) program and provide practical strategies for implementing them efficiently and sustainably. Whether your training program is just getting started or is highly mature, the tools and ideas presented here will help you optimize its effectiveness while reducing compliance risk.

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.

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 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.