Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
Product Id: 703885
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.
Product Id: 706270
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.
Product Id: 706331
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.
Product Id: 706324
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.
Product Id: 705588
This webinar will instruct participants on how to best recognize and understand operational risks, emerging trends, and how to establish great risk management techniques over this risk area.
Product Id: 706379
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.
Product Id: 706325
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.
Product Id: 706274
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.
Product Id: 706124
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.
Product Id: 703561
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.
Product Id: 706008
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.
Product Id: 706322
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.
Technical and Strategic Considerations in Performing Food Safety Management Systems Gap Assessments (Session I)
Product Id: 706298
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.
Product Id: 705348
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.
Vicki M. Lambert
Product Id: 704126
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.
William Mack Copeland
Product Id: 702868
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.
Product Id: 706269
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.
Product Id: 706289
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.
Product Id: 706268
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.
Product Id: 706247
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.