Search Trainings
FDA’s Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system v ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Nov 20, 2019
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries.Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented.Human errors start at the design stage.Fro ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
- Nov 26, 2019
Understanding Initial IND Submission- The first 30 days
This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Nov 26, 2019
Proper CAPA Management
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...
- Basic
- 60 Mins
- Danielle Delucy
- Dec 04, 2019
Laboratory Accreditation – Getting There Is Just the Beginning
ISO/IEC 17025 is the international standard for the General requirements for the competence of testing and calibration laboratories and is in the process of being updated and revised. What are the changes and how will they impact your current Quality Managemen ...
- Intermediate
- 60 Mins
- Michael Brodsky
- Dec 09, 2019
How to Write Sop'S that Avoid Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...
- Advanced
- 90 Mins
- Ginette Collazo
- Dec 11, 2019
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas will be discussed; incl ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Dec 19, 2019
The Use Of Statistical Process Control (SPC) Using Control Charts To Maintain Compliance In The Laboratory
Statistics can be used to monitor critical variable in the running of a procedure and in the performance of the instrumentation that performs it. By applying Nelson’s rules this data can be evaluated as performing as expected or performing in ways that are sta ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the r ...
- Intermediate
- 90 Mins
- Joy L. McElroy
EN/IEC 62304 - Is your Medical Device Software Out of Compliance?
This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for ...
- Basic & Intermediate
- 60 Mins
- Nancy Knettell