Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting.This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this sessi..
Bad attitudes, jealousy, and disruptive behavior will sabotage morale, lower self-esteem while reducing teamwork and productivity. When toxic behavior infects an organization at any level, managers may be tempted to ignore it or give in, absolutely the wrong thing to do, and tolerating it is not a solution.This session will show you how to neutralize gossip and put a system in place to ensure it does not re..
The threats and risks from human resource management issues are increasing. No longer measured in only fines, penalties, and awards for non-compliance, human resource management affects keys business metrics, including the organization’s valuation and credit rating. Further, improper human resource management can significantly reduce managerial prerogatives, and seriously damage the organization’s reputatio..
This webinar will cover the tax compliance for employee business expense reimbursements under both accountable and non-accountable employee business expense plans. Accountable plans allow the employer to exclude expense reimbursement from employee wages. Accountable reimbursement plans have strict documentation and recordkeeping requirements and require timely reporting and return of excess reimburseme..
How to Structure and Write a Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) in Accordance with OSHA 1926 – EM 385
Using a JHA to help organize your job and predict and eliminate incidents, errors, accidents, failures, poor quality outcomes, etc. has become an accepted norm in the construction business. Learning the key elements and steps, the vocabulary and definitions is an important step in the process; these will be covered in our Webinar.The process can be a little confusing to the uninitiated. We will review the m..
Take control of your time...and get control of your entire workday!The speed of everything has changed. Are your time management skills up to the challenge?Do you put off more today than you can ever accomplish tomorrow...exhaust yourself by 4:00 p.m. with only a fraction of your work done...see yourself as a decision maker who never gets around to making decisions...dread the next business meeting—or worse..
When it comes to dynamically look up and retrieving information from small or huge tables of data Lookup functions can elevate you to a new world of accuracy, productivity and time savings in Excel.To work efficiently with lookup functions you must start with clear understanding, good habits, and application of correct structure and syntax.This course effectively teaches lookup techniques and demonstrates p..
Drug product performance, in vivo, is defined as the release of the drug substance from the drug product leading to the bioavailability of the drug. The evaluation of drug product performance relates bioavailability to the therapeutic response and adverse events. Bioavailability and bioequivalence studies are measurements of drug product performance and can be used to evaluate new drug formulations, changes..
Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)
This webinar is designed to help pharma companies through the various key aspects of the Chemistry Manufacturing and Controls (CMC) information expected by FDA in an IND (Investigational New Drug) Application. The presentation will cover the key aspects of CMC package. And will explore the individual requirements across both the Drug Substance as well as the Drug Product sections of the CMC package.Learning..
In the workplace, you might think that being accountable means you're the one who gets blamed when things go wrong. In fact, accountability is about helping people to take responsibility for their obligations.It's up to you to make sure your team knows what they are supposed to do and that they have what they need to get the job done. This webinar gives you the tools to hold your employees accountable and c..
ADA Accommodation and Compliance: What should the Process between Employer and Employee should look like?
This webinar explores the issue of what should the process be between employer and employee when trying to accommodate individuals with disabilities while complying with the Americans with Disabilities Act. All companies, employees, and applicants for employment that want to learn about who is covered under The Americans with Disabilities Act (ADA), as amended (ADAAA) by should attend this webinar to o..
Allergens are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods. It is the largest area for recalls in the US and growing at a staggering rate. Anyone wanting to know how to approach, improve or review their Allergen Management Program should participant to understand the latest information for Best Practice preventative controls. Important elements will inc..
So, you’ve just been promoted. There are few career moments as exciting and these days as perilous as becoming new a team leader or manager of a department or business unit.Moving into a managerial role requires the development of leadership skills and techniques to enhance your personal and team outcomes. Leading others requires a greater level of self-awareness and core skills such as strategic thinking, ..
The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tends to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, the clinical hold, or ..
Attendees will learn about the different elements that make up a standard procurement procedure. The topic will cover those looking to improve or change a current procurement policy or program and also for those starting from scratch. Attendees will learn about technical areas to include in structuring a new or improved procedure or program and then will follow along on a real case study involving creating ..