This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections, rehearsals and preparation for successful facility inspections, and response to findings by regulatory agencies. Why should you Attend: Good manufacturing practice (GMP) is the minimum standard that a manufacturer must meet in their production processe...

This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them Why should you Attend: The attendee will learn what is important in facility design from the FDA and regulatory standpoint. The attendee will understand what FDA looks for during a facility inspection. The attendee will be able to...

Financial institutions have long been the payments engines for their customers. However, with heightened competition and the advent of new non-bank entries into the marketplace, financial institutions have been playing more defense than offense. Why Should You Attend: This webinar is designed for professionals in every bank and credit union area to develop and maintain payments as the core business practice for their customers. Every transacti...

Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job. Why should you Attend: Although it is perfectly possible to use Excel without ever creating a...

During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so the product temperature may have to be much lower that the actual freezing point of the solution before freezing occurs. Why should you Attend: The fundamental principles and technology are coupled with practical aspects of lyophilization in the training program. The long term training sessions include participants...

Have your employees, employer or client asked you: What can you pay employees and it not taxable as employee wages? Why did you put my car allowance in my W-2? Why are my moving expenses in my W-2? Are the education expenses you paid for me taxable? What kind of non-taxable benefits does your company have? If you've been asked any of these questions, this is the course for you. Why should you Attend: Taxable and nontaxable fringe benefit are s...

The Webinar will discuss the practical distinction between and method validation and method verification and the requirements of each analytical approach to comply with ISO/IEC Standard 17025:2005 for a microbiology laboratory accreditation. Areas Covered in the Session: The difference between method validation and verification The performance characteristics for method validation Performance requirements for method verification How to impleme...

Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. Why should you Attend: The reason for attending would be to gain a perspective and understanding of the proper application of risk assessment. The proper practice of Risk Assessment is the curre...

This webinar can help you be more professional and polished during an inspection. You will learn how to present information about your quality system in the most competent and professional manner. Why should you Attend: This webinar can help you prepare a strategy and detailed plan to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection. If you've had a recall, an increase in MDRs, or it's been more than 2 y...

In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820. Why Should You Attend: If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a differe...