Check out the interactive, knowledge sharing industry webinars during November and December 2020!
Unfortunately all in-house training sessions have been cancelled for the remainder of the year due to the Covid -19 pandemic
Contact us to customize an interactive and discussion format webinar to suit your company's training needs
Note: All webinars are currently being delivered using a Zoom platform. If you are interested in a webinar and cannot access Zoom or Skype for Business, please contact us.
Thanks to all who participated in one or more of the Social Brain Break sessions. They were lots of fun! Watch this space for the return of this popular event
WEBINAR: Tuesday 10th November 2020, 9.00am - Noon EDT, Cost $345 CDN plus HST
Enhanced Approach Versus Traditional Approach for Analytical Procedures.
What are the differences?
The simple answer is that the Traditional Approach refers to what we have been doing for years. The Enhanced Approach considers and integrates the key concepts and strategies of QbD and Lifecycle management.
There are significant differences in the two approaches. One of the major ones is that the Enhanced Approach requires a different mindset and requires a shift of focus onto the quality of the data generated by the procedure rather than being on the procedure itself. Although it requires more work upfront, the enhanced approach does result in more robust methods throughout their period of use and saves time on root cause analysis investigations when performance problems occur during routine use. Application of the enhanced approach can also increase the success rate of method transfers.
This webinar summarises and discusses the differences between the two approaches and provides a solid introduction to adopting the modern tools into your analytical procedure lifecycle.
WEBINAR: Friday 13th November, 2020, 9.00am - Noon EDT , Cost $345 CDN plus HST
Are you getting the most from your Self Inspection (Internal Audit) Program?
Most companies check the compliance box and meet the regulatory requirement to have a self inspection program in place. It is often designed only to monitor compliance with current GMP regulations and company SOPs. More often than not it happens once a year and bogs down QA resources. Did you know, it can do so much more?
In fact the self inspection program is one the most powerful tools you have in your Quality Management System toolbox. Unfortunately, it is seldom designed to its maximum potential.
This 3 hour webinar offers advice on how to get the most from your self inspection (Internal audit) program
Laboratory Transfer and Verification of Analytical Procedures - Integrating Future Philosophies into Current Practice
WEBINAR: Tuesday 17th November, 2020, 9.00 am - Noon EDT , Cost $345 CDN plus HST
Laboratory Transfer and Verification of Analytical Procedures - Integrating Future Philosophies into Current Practice Technical
When you try to transfer or verify analytical procedures, is it frustrating and time consuming? Do methods which have been transferred still give issues in routine use? Would you like your procedures to be more robust with fewer problems throughout their lifecycle?
If you answered yes to any of these questions, then this webinar is for you.
In this 3 hour webinar, modern concepts such as QbD philosophies i.e risk assessment and method understanding are combined with our current practices to ensure a smoother method transfer process, a more robust performance, leading to fewer lab incidents/OOS results due to poor procedure perfomance in routine use.
WEBINAR: Tuesday 24th November, 2020, 9.00am - 11.30pm EDT , Cost $320 CDN plus HST
Preparing and Understanding the Method Transfer Process (For QA Personnel)
Failures during method transfer continue to be a burden in the pharmaceutical industry, in particular for Importers/Distributors. The country from which we import the drug states the analytical procedure had been validated. Our contract testing labs are approved by our government agencies to test these products and the labs are generally extremely competent. So why do we still have problems?
This 2.5 hour webinar explains the process of method transfer from a non technical perspective for QA staff in a way that can help you communicate with the testing laboratories to improve the success rate of method transfers and gain an understanding of your procedure and the transfer process.
WEBINAR: Tuesday December 8th, 2020, 9.00am - Noon EDT , Cost $345 CDN plus HST
Quality Agreements in the Pharmaceutical Industry
Quality Agreements are a necessary, integral part of ensuring the delivery of safe medicines. Writing a quality agreement can be overwhelming. This webinar includes an overview of regulatory requirements for Quality Agreements, common mistakes when writing them and a practical component to assist you in writing your own Quaity Agrements based on your company's outsourced activities.
The material is based on FDA, European and Health Canada guidance’s for Outsourced activities.