Compliance Training Webinars for Regulated Industries

This webinar will review the global regulations pertaining to spices, herbs and their extracts used for flavors as well as an overview of all flavor regulations. It will also go into detail about spice/herb as well as flavor guidance documents from trade organizations, international & regional regulatory bodies and specific country regulations.

This webinar provides some practical and useful answers to the question: “How Large a Sample Do I Need?” Methods for determining appropriate sample sizes in raw materials acceptance, finished product release, process and product development experimentation and process monitoring for process stability and capability is discussed. A comparison is made of the square root (n)+1 sampling rule with the ANSI Z1.4 sampling system for process monitoring including incoming raw materials, in-process manufacturing and finished product. The value of a systems approach to sampling and practical tips, traps and guideline for sampling is discussed. The presentation includes portable methods for making power calculations for experimental design. The concepts and methods involved are introduced and illustrated with pharmaceutical and biotech case studies and examples.

FDA regulates how firms advertise and promote their products in social media. It creates a regulatory risk for enforcement action when firm’s step over FDA’s somewhat mysterious advertising and promotion boundaries. What you or someone else says about your product, whether true, false or misleading, becomes a target for FDA’s legal hammer. FDA can levy fines or issue Warning Letters. Even an injunction or prosecution may end up creating a corporate crisis and confusing your customers and drive them away.

Understand the paradigm shift in credit risk, market risk and risk regulation. In this webinar training, we will prescribe an antidote against the dust of old risk management thinking, and submit views on what the post-crisis risk management ideas may be.

This course will demonstrate the process of analyzing patient denials for trends related to participation in a clinical research study and leveraging this information to influence the coverage determination during Medicare Coverage Analysis (MCA) process. Participants will learn a 360 approach to increasing CRB compliance and reducing the burden to the patients participating in clinical research studies.

In this training program, attendees will understand when and why to apply DOE (design of experiments). They will also learn to identify and interpret significant factor effects and 2-factor interactions and develop predictive models to explain and optimize process/product behavior. Applying efficient fractional factorial designs in screening experiments will also be discussed.

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 easy-to-follow webinar training will illustrate the use of Pivot Tables, Pivot Charts and Pivot Table Slicers to analyze sales data by state, sales person and sales location. Pivot Tables are very versatile and allow the Excel professional to rapidly change rows, columns, and more to slice and dice raw data for detailed analysis and presentation. These same Pivot Table tools can be used for accounts receivable, inventories, personnel and much more.

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.

Attend this webinar to get a condensed overview of 21 CFR Part 11 and the key practices that deliver the best results. It will direct you to the most critical and cost-effective methods, techniques and tools available.

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 equipment qualification and validation webinar will help you to understand the various processes of equipment qualifications (IQ, OQ & PQ) and process validation steps (when, what and how to tests) in a manufacturing process. It will also highlight all the requirements of FDA cGMP regulations that all equipment to be qualified and all manufacturing processes to be validated if problems are encountered changes have to made and periodically as necessary.

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.