Stress, uncertainty, and crisis impact how we communicate and how we interact with our colleagues and customers. During the beginning of COVID-19, we saw a focus on patience, support, and collaboration. Now, we are seeing that patience is waning. Expectations are higher. And negativity is on the rise. How do you ensure that this negativity is not toxic and contagious within your team?Through COVID-19 we are..
Your company just received a large order from a brand-new customer, and they are anxious to get it shipped. However, as you try to pull a credit report you are not able to find anything of substance on this potential new customer, what do you do? This webinar will give you tools that you can use to help find out more about this potential new account, how to work with your sales team to get them educated abo..
If done right an investigation can help get to the bottom of things. If done wrong, it all too often makes things worse. So, it pays to know how to do it right every step of the way. The challenge of complying with all applicable standards/regulations is to educate and update all who are responsible for conducting investigations within the organization. Otherwise, they may not have the tools or skill sets t..
Technical Succession Planning for Knowledge Workers: Recruiting, Training, Retaining Knowledge Workers and Transferring their Technical Knowledge
Most of the time, when we think of succession planning we think of preparing people for more responsibility and for vertical promotions up the organization chart. But succession planning can also be focused on the unique issues associated with such knowledge workers as engineers, research scientists, mortgage bankers, actuaries, IT professionals, and others who are hired for what they know rather than who t..
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods, and complex filing systems for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry. As is often the case, automation and compute..
You’ve heard the statement, “If it’s not written down, it didn’t happen.” The human resources mantra to managers and supervisors is to "document, document, document," because disciplinary actions can often give rise to claims of discrimination, leading to high costs of litigation. But do your managers and supervisor know how, when, and what to document? Although it may seem like a headache to write a report..
Aside from regulatory requirements, liability for the safety of an organization’s food products will be covered. The importance of documentation control is critical in this area. Often logistics organizations do not realize the required FSMA elements, which will be covered in detail. Areas CoveredFSMA (Food Safety Modernization Act), a game changerIt’s about Prevention, ensuring safe food products for..
Workplace drama sucks the productivity out teams and organizations. It also creates an inhospitable environment where healthy people don't want to work ... so they leave. Good, productive people leave the organization. In fact, the best people, the highest performers, the self-directed, the most creative, those that need little oversight, are most likely to leave. Why? So much time and effort is required to..
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, the environment, and the like. As such, there is no one size fits all investigation. Microbiological testing covers a wide range of products, processes, and envi..
Succession Planning for 2022: It's Not Just for Emergencies - It's a Leadership Development Strategy
2022! Life and the workplace have changed and will continue to change. What will the new normal be like? For most organizations and their leaders, the new normal is and will continue to evolve for some time. So, why be concerned with succession planning when you, as as a human resource or senior or line manager have so many other problems to deal with? The reason is that the pandemic had created..
In this fast-moving presentation, HR, engagement, and coaching expert, Don Phin, will share with you strategies and tools to help you and your managers step up their engagement and performance management games by learning how to coach their direct reports. Coaching helps for a myriad of reasons. The best managers and employees want to improve their ability to engage everyone from board members to the rank a..
The Differing Site Conditions clause is one of the oldest clauses used in construction contracts, having been created by the U.S. Federal government in 1926. It is generally accepted that the object of the clause is to transfer the risk of latent site conditions to the owner, thus enticing contractors to reduce their contingency cost at the time of the bid. The promise of the clause is that if the contracto..
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approvalto produce a U.S. generic drugfrom an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product. A generic drug product is equival..
This course will demonstrate how to use Excel to perform custom calculations based on the topic of housing data analysis. The attendees will learn the formula language and become comfortable with how to create any calculation.The attendees will also observe a Pivot Table process using the same housing data and then a final presentation of that data in a publish-worthy report layout.Areas CoveredCalculate av..
Good Documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general ru..