Search Trainings
Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be disc ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Jun 19, 2019
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented w ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Jun 25, 2019
Compliance for Risk Based Approaches for clinical trials including the New FDA RBM Guidance 2019
Risk management is becoming increasingly important for running clinical trials. There are now numerous pharmaceutical guidelines covering risk assessment and management and Risk-Based Monitoring (RBM) including the revised ICH GCP R2 guideline, EU Clinical Tri ...
- Basic & Intermediate
- 60 Mins
- Laura Brown
- Jul 18, 2019
Effective Batch Record Review
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of ...
- Intermediate
- 60 Mins
- Danielle Delucy
21 CFR 111 GMP Dietary Supplement Laboratory
This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested It will futher review the test procedures and documentation requirements to ensure regulatory compliance ...
- Basic & Advanced
- 60 Mins
- Gwen Wise-Black
Process Validation for Drugs and Biologics
This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. Attendees will learn how to establish an effective process validation system and inte ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
How Medicare’s Market-Based Payment System Is Upending the U.S. Clinical Laboratory Industry
Starting in 2018, Medicare reimbursement for most high-volume and many other laboratory tests are seeing reductions of up to 10 per cent for each of the next three years, followed by up to 15 per cent for each of the next three years as required by the Protect ...
- Intermediate
- 90 Mins
- Dennis Weissman
Validation of Complex Cell-Based Potency Methods
This webinar will address development and validation of complex cell-based methods some cell-based methods are multifaceted Will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, Will also discu ...
- Basic & Intermediate
- 60 Mins
- Gwen Wise-Black
Steam Sterilization Microbiology and Autoclave Performance Qualification
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization proc ...
- Basic & Advanced
- 60 Mins
- Danielle Delucy
Standadardizing Operations to Eliminate Human Error Potential in Life Sciences Operations
Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrence in pharmaceutical manufacturing. It occurs even ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul