Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management
Complaint handling is essentially the beginning of the process if not one crucial aspect of the process of collecting data concerning the product that is in the marketplace. It is your first “tip-off” that something might not be going as intended. Complaints are ignored at your peril and ignoring them results in a significant risk to the organization and to the patients that use your products.Complaint hand..
Complaint Handling and Management: From Receipt to Trending
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..
Implementing the ACA, HIPPA, GINA, ADA, and Title VII Discrimination Laws into Your Organization’s Wellness Strategy
The federal government believes wellness programs can cut healthcare costs and decrease the cost of employer-sponsored health insurance by promoting health and preventing disease. The new federal regulations have divided wellness programs into two types with specific rules for each. A major piece of the regulations addresses the issue of employment discrimination based on health/disability, age, gender, and..
IRC 199A – The New 20% Tax Deduction of Business Income
IRC 199A, the new 20% of qualified business income deduction, is the best new tax deduction from the Tax Cuts and Jobs Act. The deduction has a lot of complexities to it, and without proper knowledge of how the deduction works, taxpayers can see large penalties and taxes due. This webinar will look at all the different scenarios involved when calculating the IRC 199A deduction. It will also look at differen..
Preventing Harassment, Discrimination and Bullying in the Workplace: Today’s Climate Update for 2020 and Beyond
This one hour course is designed for all employees in your organization. It is intended to help employees learn how to behave appropriately in today’s workplace.It has become clear that complaints are being made and honored about behaviors that in the past had seemed “too mild” to worry about. Only egregious sexual misconduct was brought to the attention of those in charge. Not so anymore. Today, even the m..
Asset Based Lending: Policy and Underwriting Guidance for Borrowing Base Lending on Receivables and Inventory
Asset-based lending (often referred to as “ABL”) is a form of commercial lending designed to finance safely the working capital needs of a borrower whose cash flow may not support debt repayment. Like other commercial loans, cash flow is the primary repayment source for an asset-based loan but with a stronger reliance on the company's assets as collateral and firmer control over the receipts of the collater..
Biomarkers in Drug Discovery and Development
High development costs and low success rates in bringing new medicines to the market demand more efficient and effective approaches. The FDA supports model-based drug discovery and development. This represents a mathematical and statistical approach that constructs, validates, and utilizes disease models, drug exposure-response models, and pharmacometrics models to facilitate drug discovery and development...
How to Keep HR From Being the Employee Complaint Department
It seems that HR has become the place where employees go to vent about every petty slight or departmental squabble. And employees somehow expect HR to instantaneously fix them and smooth over all of their workplace-related issues. Certainly, when employees come to HR to lodge legitimate complaints of harassment, discrimination, or retaliation, of course, HR must listen, document and investigate. However, th..
Team Building Necessities to Sky-Rocket Productivity
Teams are the way organizations get their work done and bring innovation and creativity to their industry. In this one hour webinar be prepared to learn how compensation is not necessarily the driving force behind high performing team members. By spending time and money on building capacity on a team through training, coaching and mentoring, organizations save money in the long run and build highly effectiv..
Proper Execution of Aseptic Process Simulations
Aseptic processing, the technique used to ensure sterile drugs are packaged in sterile containers, is one of the most important steps in biopharmaceutical manufacturing, because of the risk that contamination poses to patient safety. An Aseptic Process Simulation is performed by these biopharmaceutical firms to ensure the process can be performed with minimal contamination. This is accomplished by using a g..
Advanced Auditing for Data Integrity
Any successful records management plan will start with an assessment of your current state. Data Integrity audits will ask :Where are your records, what are the formats, how are they being tagged and classified, what kinds of policies are you applying to management and how well and consistently are you enforcing those policies?Learning ObjectiveLearn how to apply consistent meta tags to all documentsLearn h..
Creating Civility in the Workforce – Whatever Happened to Respect?
Don’t let anyone get comfortable by disrespecting you, your work skills, your ethnic background, your soft skills in leadership and communication, your department, or your work team. Uncivil and disrespectful behavior, when left unchecked, becomes the culture of being rude, indifferent and uncaring. This generates gossip and rumors. Gossip is someone trying to level the playing field by taking away what som..
Managing Non-conforming Material and Failure Investigations
Non-conforming material happens. And medical device companies must deal with it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and correctiv..
Overseas Retail and Consumer Compliance: Risk and Compliance Abroad
The demographic, economic, and immigration trends of financial institutions over the past few decades has resulted in significant shifts in the portfolio of financial services consumers. Financial institutions are developing a more global platform for financial products and services. Contributing to this trend is the rise of digital technology, which has dramatically expanded the territorial scope of consum..
Tactical Planning with Demand Driven S&OP
Companies are facing an ever more increasingly complex environment coupled with increasing marketplace volatility. This is causing companies to strive to be more flexible and responsive by streamlining both planning and execution. In addition, companies are attempting to conserve the use of their valuable resources. Instead of investing in products prematurely that then creates an inventory that may not be ..