Compliance Training Webinars for Regulated Industries

This course is to provide the participant with a general understanding of the recently signed ECONOMIC AND TRADE AGREEMENT BETWEEN THE UNITED STATES OF AMERICA AND THE PEOPLE’S REPUBLIC OF CHINA. It provides a summary of each chapter of the agreement and commentary as to how the participants’ business may be affected by it.

Pretreatment technology is quite diverse with many tried-and-true options. This seminar describes and identifies new and innovative technology which can eliminate many traditional pretreatment modules. The new ISO-22519 elucidates on many pretreatment issues which will be discussed. ISO is a voluntary standard which may be instituted by a company and is often quoted or cited by a regulatory agency. This presentation offers ideas, physical modules, and descriptions of alternative pretreatment options.

This training program will explain how to conduct motivational and directional performance appraisal reviews meaningfully and effectively. It will help in motivating employees to achieve goals and increase their value to the organization.

This course is designed for anyone who is interested in a new job or a promotion. We start with helping you look at yourself, your values and interests in a new way – because we believe your happiness is important. Next, we offer suggestions for various marketing aspects, including creating your brand, your positioning statement and other marketing aspects of yourself.

This webinar will highlight the importance of quality by design (QbD) concepts via the early establishment of control strategy approach to facilitate the development of robust manufacturing operations associated with biologics and/or pharmaceutical manufacture.

This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.

This course will focus on Regulatory Interactions with Health Authorities. It will go over the basic types of meetings, correspondence, and committees which companies may use to interact with Health Authorities.

CMS has changes to evaluation management coding for 2020 and 2021. The 2020 changes are significant and include new services and expansion of existing services. The changes finalized for 2021 include major changes to the physician requirements for documentation related to evaluation management coding.

This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.

This course will describe the Medicare Coverage Analysis (MCA) process and the revenue cycle’s uses for this document. The course will describe the creation of the MCA and the multiple uses for this document.

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

What has been the sum impact of this dizzying array of action for U.S. businesses and the American economy? What can corporate America expect in the final 18 months of his first Administration? What are his chances for re-election? And If he wins again, what can we anticipate in term two? In this webinar, get perspectives about these and more.

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 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.