The topic is for all those with an interest in the rules and requirements for the manufacture of medically active substances for use as starting materials in the manufacture of human or animal medicines. We look at the development and manufacture of chemical, biotechnological and biological components of drug substances. The basis of the criteria to be met to release material for shipping and downstream pro..
This training focuses on basic HIPAA Compliance training revolving mostly around Title II of HIPAA, Administrative Simplification. Participants will learn broadly about the enactment of the Healthcare Information Portability and Accountability Act and modifications and changes since the Act was established in 1996. Specific attention is paid to creating and maintaining properly printed and/or digital patien..
Leveraging your sphere of influence is critical to the success of your company. Yet many companies fail to market to their SOI. This can result in lost revenue for the company that will make it hard to compete, let alone thrive.This presentation will identify what SOI Marketing is. Who you consider as your SOI. What foundation you will need to lay in order to market to your SOI properly. When you should mar..
Are you responsible for payroll or employer tax withholding compliance? Or maybe you were recently hired or promoted to the payroll department. During your indoctrination, you are surprised at all the interesting things to do and how important this role is to the success of the company. You begin to wonder just how much there is to learn. Join us for a quick briefing on the basic laws affecting payroll. Lea..
This course will discuss the procedures and processes your BSA department could consider using when your institution is clearing and disposing alerts for potential hits identified by your screening process related to companies, individuals, and countries identified by government, international, internal, and other lists as sanctioned or of concern for money laundering, terrorist financing or other criminal ..
Businesses are buffeted by turbulence and change on a continuing basis. There are numerous examples of companies and entire industries that have not been prepared for shifts in the economy, technology, competitors and other external factors; and, in some cases, their very existence was threatened. Strategic Workforce Planning (SWP) is a discipline that enables organizations to prepare for different futures,..
The hazardous waste rules including the generator standards have been in existence since 1980. In 2016, EPA recently revised the standards with the intent of simplifying the generator rules. This training will summarize new requirements, address in which states the requirements are currently effective and review the other requirements for hazardous waste generators.BackgroundHazardous Waste IdentificationCh..
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for. Anyone in a medical device se..
You will learn what export documentation is required to comply the with Bureau of Industry & Security (BIS) and Foreign Trade Regulations (FTR). The webinar will discuss AES and how the Census Bureau collects Electronic Export Information (EEI) and what are the mandatory export data elements. The webinar will include the USPPI responsibilities and how this can change depending on the Incoterms of the ex..
This program will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discusse..
This webinar will cover the basics a Supervisor needs to know regarding how to handle common people problems. While there is no program that could cover all conduct of what people could do, we will cover the most common problems.We will also cover the basics of discrimination, harassment, safety and WC, and the rights to leave. Wage and hour are important too and we will address the most common mistakes tha..
This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide with method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the produc..
The loss of potency during storage may influence the efficacy and safety of pharmaceuticals. Pharmaceutical products require controlled storage and transit conditions in order to ensure that their quality is not compromised. Storage is an important aspect of the total drug control system.Proper environmental control (i.e., proper temperature, light, and humidity, conditions of sanitation, ventilation, and s..
Learn how to avoid the legal risks associated with the use of social media in the workplace and how to develop and implement effective social media policies.Most employers don't really want to know what their employees did last night, but they might find out on social media. This session will examine social media in the workplace and will address how to avoid legal risks associated with monitoring and disci..
Financial Statements and accounting information are often constrained by various conventions and rules imposed by IRS, other tax authorities, the Financial Accounting Standards Board, Generally Accepted Accounting Standards, etc. Moreover, the computerization of accounting has tended to confine managers to specific formats and presentations that do not grant the flexibility for innovation in an analys..