Search Trainings
How to get a 510(k) for a Machine Learning Product
We will explain what a 510(k) is and explain the other FDA regulatory pathways. We will discuss how software can be considered a device by the FDA. The procedure to obtain a 510(k) will be explained. The contents of the submission to the FDA will be explain ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Mar 23, 2023
Medical Device Software Validation Meeting FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Mar 28, 2023
Current GXP expectations on Water system validation compliance
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...
- Basic & Intermediate
- 90 Mins
- Hitendra Kumar
- Mar 31, 2023
Biomarkers in Drug Discovery and Development
Biomarkers are a key medical product development tool capable of facilitating the development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treat ...
- Basic & Intermediate
- 60 Mins
- Stefano Persian
- Apr 05, 2023
Validation Sampling Plans
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation w ...
- Intermediate
- 60 Mins
- Alan M Golden
- Apr 07, 2023
Validation Sampling Plans
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation w ...
- Intermediate
- 60 Mins
- Alan M Golden
- Apr 07, 2023
Human Error Solutions: How We Reduced 60% Of Human Errors In Less Than A Year, A Case Study
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain the status of high-performing organization manufacturing sites are implementing strategies and practices like ope ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Apr 12, 2023
The Importance of Packaging and Labeling in Pharmaceutical Product Development
Occupying a critical position in the success or failure of any pharmaceutical product launch or revision, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compl ...
- Basic & Intermediate
- 90 Mins
- Michael Esposit
- Apr 17, 2023
Implementing a Robust Supplier Management Program
Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standar ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Apr 19, 2023
Extractables & Leacheables in Drug Development
An effective extractable and leachable evaluation is essential for the overall success of any pharmaceutical drug development program for both small molecules and biological agents. In this webinar expert speaker, Stefano Persiani will focus on the basics of a ...
- Basic & Intermediate
- 60 Mins
- Stefano Persian
- Apr 21, 2023