The logistics of payroll record keeping can be daunting. At least a dozen state and federal regulatory agencies require access to your records. All have different requirements as to content and storage requirements. Electronic records are ok in some cases, paper required in others. In some instances, you have to keep the records forever.Records come from various departments, offices, sources, etc. They vary..
The Model for Improvement methodology applies to any industry, organization etc. that is interested in solving the problem with transactional or manufacturing processes. Areas CoveredCost Justification: What is Your Organization’s Sigma LevelImprovement Team SelectionHow to collect Process Information Without BiasIntroduction to the Model for ImprovementHow to apply The Model for ImprovementIdentify Pr..
Supply Management is about buying the right thing, at the right time, at the right quality, at the right price, from the right supplier, in the right way. In order to do these steps “right” requires skill sets in many analytical techniques. This webinar covers some of the basic analytics that purchasing and contract personnel use to obtain maximum value for their organizations. Show how Purchasing Savi..
CMO Supplier Quality Agreements - What you Need to Know to Comply with New FDA & EU GMP Guidelines for Contract Drug Manufacture
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:EU GMP Chapter 7 "Outsourced Activities" January 2013Guidance for Industry -..
This program will review the current rules and regulations from the Conditions of Participation for discharge planning. We will then discuss the most recent changes from the Medicare program and how they will impact the roles of the RN case manager and the social worker. We will review strategies for safely transitioning your patients across the continuum of care. In addition, we will review how to engage o..
The US FDA receives over 100,000 reports a year of medical device adverse events including deaths, serious injuries, and malfunctions. Because of this high number of reports, the FDA sought ways to sort the data using hierarchical coding systems that included a device problems code; a manufacturer’s evaluation fo the event: methods, result, and conclusion; and also information on the patient and the device ..
This session will provide an in-depth tour of customer services practices around the world and concentrate on customer retention and process effectiveness. Today’s changing technology landscape and the advent of multicultural and intergenerational customer service practices makes more important than ever to address how to reach mass audiences and cater to their specific needs. The session is structured to i..
Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. However, integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals often..
What You Should Know About Export Requirements for FDA Regulated Products from the US to Foreign Countries
This training will provide an in-depth explanation of FDA-Regulated Products that were exported from the United States to Foreign Countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products. Then, it also will discuss the FDA procedures that exporter must comply to in order to meet the Modernization Act agreement. Lastly, it explains what local gov..
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..
The training will focus on 3 areas - creating summary reports using Pivot Tables; creating eye-catching charts and presenting geographic-based data.In the pivot tables section, you'll learn how to create a basic pivot table, display numbers as a percentage (no formulas, arithmetic or programming required!), and make the pivot table eye-catching appealing to read and then group the data (by month or numeric ..
Many people feel overwhelmed when faced with the daunting task of documenting their company’s Sarbanes-Oxley controls. This presentation will help you to confidently deliver SOX documentation which auditors and executives are pleased to sign. The SOX documentation process does not have to be complicated. This presentation will show you how simple it can be.Documentation is simply writing down what it is tha..
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.Learning ObjectivesAtten..
Human resources analytics is a very hot area in HR today. Many HR professionals think it is new but it has been employed since the 90’s. Basically, analytics is a combination of analysis and statistics and unlike metrics which are data from the past; analytics is the use of data to make predictions about the future. This webinar will detail how, with the right data and skills, an HR professional can:Make pr..
The Medical Device Single Audit Program (MDSAP) is a process that allows a single audit to occur of a medical device manufacturer's Quality Management System to determine if it satisfies the requirements of multiple regulatory jurisdictions.The MDSAP Audit is a one-time audit for compliance with the regulatory requirements of five current participant countries: Australia, Brazil, Canada, Japan, and the Unit..