Compliance Training Webinars for Regulated Industries

In this webinar, we will review in detail major considerations to be well-thought-out during the prescription drug product development process. We will review in depth FDA cGMPs and their importance in drug manufacturing. We will review the submission process and post-approval commitments. This webinar is Part 2 of a 2 Part series.

Attend this webinar to understand the definitions of in-house IVDs, the regulatory requirements including classification & essential principles, the NATA requirements related to how and when IVDs can be used as a research or diagnostic tool and the current laboratory supervision requirements for the ability to perform and report on in house IVDs.

This training program will highlight common issues that occur over time with material compliance programs, and demonstrate how to address them. This can result in a more effective and responsive material compliance effort for your company.

The webinar covers the need for understanding the ISF 10+2, 10+5 and its processes. The reason for filing the ISF, when to file the ISF and who files the ISF.

This webinar will review in depth FDA and other important US Regulatory Bodies roles and responsibilities pertaining to the prescription drug development process. We will explore the recognized regulatory approval pathways, good clinical practice and clinical study concerns.

In this webinar, get an overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. It will cover pertaining regulations and their applications to provide success when being reviewed by an auditor.

Attend this webinar to get an overview of the recent Brazilian changes regarding the big data protection in Regulatory Affairs. It is an opportunity to analyze and discuss key issues related to the data protection applicable to all medical, pharmaceutical, food and cosmetic product.

Information Technology (IT) is a critical enabler of business. Assuring an enterprise's governance, including risk management and control processes, requires auditors to understand the role of IT within their organizations and to develop adequate knowledge and skills to audit IT systems as the line separating "IT" and "non-IT" audits are beginning to disappear, except in the very technical IT domains. This course is designed to give non-IT auditors and beginning information security professionals an overview of the various considerations and aides in audit planning to gain a greater understanding of how to evaluate defined audit areas.

This training program will help attendees distinguish between supplemental wage payments and regular wage payments and help them identify wage payments that are neither supplemental nor regular. It will also detail methods used to compute withholding on supplemental pay including examples.

Amateur Radio’s primary purpose for existing is to provide backup communications in times of disaster. The webinar presents methods used to provide communications when Internet and Phone Systems are not accessible due to human-made or natural disasters.

Attend this highly informative 90-minute webinar to find out the different kinds of payroll scams, how to identify red-flags of fraud and how to prevent and stop payroll fraud.

In this webinar attendees will learn how to select the right management team and also understand the union team, to handle union pressure tactics, to come to an agreement.

Attend this webinar to learn the logical, fast and simple process of how to easily write any document that your company requires. Explore how to organize collected information, write the document and address the comments from reviewers and approvers.

This U.S. Customs & Border Protection (CBP) compliance training will provide attendees tools to ensure they comply with rules and regulations applicable to Free Trade Agreement (FTA) and special trade program claims.

This Webinar is geared toward those who require a working knowledge of biocompatibility.

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.

This webinar will help you to establish a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient. The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”. In order to “establish” a suitable and effective QMS, medical device companies must be able to “say what they do, do what they say, and prove it”!

This webinar will explain how to prepare a Customs manual that complies with CBP laws and regulations. Attendees will learn best practices for successfully passing an audit or becoming an Importer Self Assessment Program (ISA) member.

Join this webinar to receive instructions on the uses of, need for, setup of, and management of a Data Safety Management Committee for an FDA regulated clinical trial.

Attend this webinar to learn about the considerations which must be kept in mind before performing PCR in the Point of care format. This webinar will make sure that healthcare facilities know what is necessary to perform these tests in a simple, yet powerful manner.