New ISO14971: 2019 Risk Management Standard for Medical Devices – Implementation
Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis. The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical devices products. This process has been streamlined within ISO14971 standard and has become the best practice to show the application of risk-based approach implementatio..
Identifying, Managing, and Retaining High Potential Employees
With the economy back in gear, organizations need to work even harder at engaging and retaining their key talent; the most important group being their high potentials because these employees produce a higher level of both quality and quantity of work than others. They are also frequently the source of future leaders for the organization. Join this webinar to discover how to identify them in your organizatio..
Key Factors in Managing Settlement Risk in Foreign Exchange Operations
Since 2000 we have seen the diversification and massive expansion of the foreign exchange market. While in the past, commercial banks dominated the market; participants today also include commercial as well as investment banks, foreign exchange dealers and brokerage companies, multinational corporations, money managers, commodity trading advisors,insurance companies, governments, central banks, pension, and..
Streamlining the Month-End Closing Process
We will share best practices for closing the books, performing period-end analysis, and producing financial reports within 2 days of the month-end. We will discuss the key reasons for closing and reporting delays and how to overcome these obstacles to improve your closing process and timeline. Every business needs timely reporting at month-end, quarter-end, and year-end. Publicly traded companies have prosc..
Make Your Sales Numbers
There’s lots of uncertainty in the sales process. Are you focused on the right prospect? Are you reading those signs your prospect is sending correctly? Can you handle changes in direction that might surface during the sales cycle? These are all valid concerns for the person in the sales role. Added to these concerns is the anxiety of potentially not making the numbers you need – either as a sales professio..
NAFTA 2.0: The New USMCA and How It Will Affect You
26 years have passed since Canada, Mexico, and the US signed the North America Free Trade Agreement (NAFTA). One of the largest free trade zones in the world, NAFTA has greatly increased trade and investment among the three nations. Recognizing that the Agreement should be updated rather than scraped, the US, Canada, Mexico have agreed to renegotiate NAFTA.On September 30, 2018, the three nations signed the..
Content and Format of an Initial IND Submission 21 CFR 312.23
This webinar is designed to help pharma companies through the content and format of every module of the Common Technical Document for an Initial IND. The presentation will cover the in-depth understanding of the contents of every module in the CTD. The key knowledge to accelerate submission and subsequent commencement of the Clinical study and what more, helps bridge any gaps in terms of data or requi..
Fundamentals of Good Manufacturing Practices (GMP) - Developing a Compliance Mindset
A discussion of the basic principles and requirements for Good Manufacturing Practices. The presentation provides a brief history and basis for the existence of GMPs, a discussion of what they cover, and examples of real-life situations along with a discussion of possible responses and the reasons one or more responses may be appropriate or not.Learning ObjectivesFundamental requirements of Good Manufacturi..
GMP’s Applied to Medical Cannabis: All You Need to Know
When we discuss growing, producing, and manufacturing medical cannabis, we must think of it as a medicine. Medicine by definition is a substance intended to assist you with a medical condition, to help you feel better and not harm you. Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient. Yet when we talk process and qual..
Staff at Home: Who is Paying and Why Would You? Update on Lockdown-Costs
Working at home and sick leave are important issues within organizations; first the personal issue for the employee, secondly the production losses for the company. Who is responsible for working at home in COVID-19.Working at home: how do you manage this and what about the loss of productivity. And is there loss?Sickness is an issue in our personal lives, companies, and society; especially new in the biolo..
Step by Step Process for Successful Sterility Failure Investigations
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 enviro..
Ways Home Healthcare is Changing the Medical Device Game
Medical devices will look and feel different in the next 20 years because our design criteria are changing. Home healthcare and the demands of remote patient monitoring add a new level of complexity. Design and usability research for home-based medical devices will elicit vastly different design inputs because the user profiles are drastically different than they are at the hospital. The technology requirem..
What Your Employees Really Want, But Won’t Tell You
Keeping good employees is so much easier than finding and hiring new ones. But in a world where people always have their eye out for the next best thing, how do you know what will make top talent stick around? You could ask employees what they want, but chances are you won’t get a straight answer. Why? It’s scary to tell leaders what they’re doing wrong, but it can also be hard to articulate exactly what ne..
Business Lessons Learned from COVID-19
In our time together we will conduct and review a SWOT of our situation and provide insight and tools for the attendees to do a SWOT on their own. We will also use a PESTEL format to examine the situation and understand how this model can also be useful to our personal and professional pathway forward as well as to our businesses. We will examine the questions we need to begin answering right now to be able..
How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by the FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by wh..