Search Trainings
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, tem ...
- Basic & Intermediate
- 60 Mins
- Roger Cowan
- Sep 24, 2019
Adverse Event Reporting and Product Recalls
This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint hand ...
- Intermediate
- 75 Mins
- Joy L. McElroy
- Sep 24, 2019
Medical Device Software Verification and Validation
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
- Basic & Intermediate
- 60 Mins
- Nancy Knettell
- Oct 04, 2019
CAPA Under U.S. FDA / CGMPs and EU MDR / ISO
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus. The roles of Failure Investigation ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Oct 15, 2019
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Oct 23, 2019
US FDA’s 2019 - 2020 Strategic Priorities
In their latest strategic priority cycle, the FDA has committed to reduce the time and cost required to bring a product to the U.S. market and support it throughout its life cycle while not compromising reasonable assurance of safety and effectiveness. To achi ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Oct 30, 2019
Proper Execution of Annual Product Reviews
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. Annual Product Quality Review ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Nov 08, 2019
How to Implement an Effective Human Error Reduction Program
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. For example; The CFR - Code of Federal Regulations Title 21 Subpart B_Organizat ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation - The Requirements
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements currently being phased out and the new EU MDR Technica ...
- Intermediate
- 90 Mins
- John E. Lincoln
Analytical Equipment Qualifications, Writing IQ, OQs, and PQs
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (V ...
- Intermediate
- 90 Mins
- Joy L. McElroy