Purchasing Controls and Receiving Acceptance for Medical Devices
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ ..
Advanced Project Management Tips & Best Practices for Human Resources
Refine your organizational skills to keep your projects on time, on budget, and on target. You've learned the basic techniques of project management. You've mastered the planning, executing, reviewing, and revising skills making the difference between success and absolute failure. You are good at getting the different players and stakeholders to provide information or direction and to show up for important ..
FDA and Management Responsibility for Social Media Use
The use or participation in social media can lead to some surprising outcomes with the FDA. The sweeping statutory definition of “labeling” covers the use of information that appears in social media. There are several platforms that can present information either by you or a third-party, all of which can become an action by the FDA against the management’s actions or inactions. Firms should develop and impl..
Impact Damages – Fact or Fiction
In this webinar, industry veteran Jim Zack will discuss impact damages and what they may include. You will gain a better understanding of impact damages and the issues surrounding this form of damages. This webinar will also explore 10 types of impact damage claims. For each of the 10 types of impact damage claims, Jim will identify and discuss one or more potential defenses owners may employ to analyze and..
Importing and Exporting PPE: How to Deal with CBP, FDA, FEMA and Other Scary Agencies
The outbreak of coronavirus disease (COVID-19), first in the People’s Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries. Congress is particularly concerned about these depende..
Risk Based Computer System Validation
FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than the validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.How to plan and conduct a risk-based validation will be explained. The overall risk for a com..
Training New Technical Writers
The objective of the webinar is training to become Technical Writers. Technical Writing is labor-intensive. By that, I mean that someone learns to be a Technical Writer by creating Technical Documents. Simply stated, a Technical Writer learns to do by doing. Training for Technical Writers involve General Comments about Creating Technical Documents, actually Creating Technical Documents, understanding the di..
Biomarkers in Drug Discovery and Development
The potential benefits of a biomarker in drug development are very significant. Careful identification of the context of use is necessary for the successful use of a biomarker. Biomarker use could benefit individual patients participating in clinical trials (e.g., earlier identification of toxicity with a safety biomarker) or general drug development and regulatory decision-making (e.g., a prognostic or pre..
Crucial Compensation Conversations
There may be one thing in organizational life no HR or Payroll department wants to get wrong, that is the paycheck of any employee! This webinar does not address payroll processing. It does address how your compensation system is built on a philosophy, designed to achieve specific results from the perspective of recruiting, retaining, and engaging the workforce. Variation in approaches with different job gr..
Delegation and Communication Techniques for Supervisors
The role of the supervisor and a newly appointed manager is critical to the development of a company. Supervisors are responsible for the workers in an organization and can determine the level of success that an employee will attain. It has been said the employees do not quit the company they work for, they quit the supervisor they work for.So, it is critical that supervisors gain as much and as many skills..
Dynamic HR: How to Transition from Tactical to Strategic HR
The need for tactical human resources tasks will probably never go away, but this doesn’t mean that this is where the growth and value of HR ends. In today’s competitive business environment, people management at all levels of an organization needs to be more strategic and evidence-based. Now is the time for HR to rise above its role as the keeper of short-term, compliance-related duties and begin to intent..
Implementing a Robust and Compliant Change Control Program
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, its product, or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur. This Change Control th..
Managing Excel Data Through the Use of Sorting, Filtering, Subtotaling and Using Conditional Formats
Learning how to use efficiently use Excel is so critical in many of today’s office jobs. Many people know the basics of Excel. This webinar will show you how to use Excel’s Sorting and Filtering tools to gain control of your data. These are the first steps to being able to learn from your data. Formatting data with Conditional Formatting and being able to then sort and filter the formatted data begin your d..
Defining the Roles of the RN and Social Work Case Manager in the Acute Care Setting
The role of the case manager and social worker is dynamic and constantly changing in response to the changes in health care delivery and reimbursement at the federal, state, and local levels. While change remains a constant, there are certain core roles and functions that apply to the work of the social worker and nurse case manager regardless of job setting. In addition, case managers and social workers wo..
Front End Order to Cash Processes and their Impact on Accounts Receivable
When companies seek to improve the management of their Accounts Receivable (AR) asset, the focus is often on the “Back End” sub-processes of the Order to Cash (O2C) process. These sub-processes include Collections, Dispute Resolution, Credit Control, and Cash Application. However, equal or greater improvements can be realized by improving the “Front End” O2C sub-processes. These include Quotation, Contract ..