
The Regulation of in-house IVDs and accreditation of laboratory users in Australia
Paul Cohen
75 Min
Product Id: 706155
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.

How to Create an Effective GMP Compliant Training Program and Reduce Training Related Human Errors
Ginette M Collazo
90 Min
Product Id: 706179
Attend this webinar to learn how to create a GMP compliant training program and avoid human errors when implementing/improving a training program. It will discuss important elements like curricula, training management systems, training effectiveness and more.

Is Your Compliance Program Due for an Update?
Jim Kandler
60 Min
Product Id: 705085
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.

Achieving Sustainability Results with ISO 26000
Kelly Eisenhardt
60 Min
Product Id: 705079
The International Standards Organization (ISO) defined the ISO 26000 guideline for the use and planning of all structured, measured, and monitored social responsibility programming. This standard enables companies to initiate and track performance of CSR programs by focusing on the triple bottom line (TBL) - people, planet, and profit. This training program will offer in depth look at the key components of the ISO 26000 guideline and best practices to implement and support a social responsibility program.

Understanding the ISF 10+2, 10+5 And Its Processes
Charles Jacque
60 Min
Product Id: 706195
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.

Understanding FDAs Governance of Prescription Drug Development: Interacting with FDA, Established Pathways to Approval, cGMP and Clinical Study Concerns – Part 1
Sharon W Ayd
90 Min
Product Id: 706130
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.

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Carl Patterson
60 Min
Product Id: 706177
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.

The Big Data Health in the Brazilian Regulatory Affairs
Eliana Silva de Moraes
90 Min
Product Id: 706173
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.

Essentials of IT Auditing for the Non-IT Auditor
Robert Davis
60 Min
Product Id: 706172
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.

Supplemental Pay Essentials - Severance Pay, Deferred Compensation, Recordkeeping and Fringe Benefits
Patrick A Haggerty
90 Min
Product Id: 704112
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.

Backup Communications for Medical Facilities - New Federal Regulations Affect Healthcare Providers and Amateur Radio
Michael Abitz
60 Min
Product Id: 706171
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.

Detecting and Preventing Fraud in Payroll: Proven Strategies to Save Money
Peter Goldmann
90 Min
Product Id: 706025
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.

Changing Payroll Frequencies: How It Can Be Done 2019
Vicki M. Lambert
90 Min
Product Id: 704483
This webinar will allow attendees to gain the knowledge and insight necessary to successfully implement changes of payroll frequency for your company.

How to Comply with the Chemical Facility Anti-Terrorism Standards (CFATS)
Joe Keenan
60 Min
Product Id: 706187
Attend this webinar to understand the Chemical Facility Anti-Terrorism Standards (CFATS) in detail. Site-specific Chemical Facility Anti-Terrorism Standards (CFATS) questions and answers, as well as potential scenarios, will be addressed.

Successfully Negotiating The Labor Agreement
Gerry McLaughlin
90 Min
Product Id: 705550
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.

Technical Writing in an Industrial Environment
Robert Peoples
60 Min
Product Id: 706058
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.

How to Survive CBP Free Trade Agreement Verification
Donna L Shira
60 Min
Product Id: 703258
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.

Biocompatibility Testing; what you need to know
Mike Colvin
90 Min
Product Id: 705585
This Webinar is geared toward those who require a working knowledge of biocompatibility.

Regulatory and Testing Requirements of Bacterial Endotoxin Testing (BET) using LAL
Carl Patterson
60 Min
Product Id: 706168
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.

Say what you do; Do what you say; and Prove it! Quality Management System Essentials
Susanne Manz
90 Min
Product Id: 706167
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”!