Search Trainings
Creating Optimal Sampling Plans
A sampling plan is a term widely used in research studies that provide an outline of the basis on which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the popu ...
- Basic & Intermediate
- 60 Mins
- Yuval Shapiro
- Nov 30, 2022
The Transfer of Validated Methods
This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Dec 05, 2022
Bulletproof CAPA Process: How to do it Right?
FDA, EU Notified Bodies, and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions. Organizations should provide evidence that they have the required means and abilities t ...
- Basic & Intermediate
- 60 Mins
- Yuval Shapiro
- Dec 12, 2022
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Dec 19, 2022
How to Deal with Bad Results Under GLP
Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts a ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Jan 04, 2023
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Jan 18, 2023
Medical Device Trends in FDA Compliance and Enforcement
This webinar will focus on medical devices, a key concern for FDA as they become more and more complex, and require methodical risk assessment and mitigation. Protecting medical devices from hacking where someone can alter the actual code embedded in the devic ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 01, 2023
Best Practices in Preparation for an FDA Audit of Regulated Computer Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer sys ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 20, 2023
Best Practices in Preparation for an FDA Audit of Regulated Computer Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer sys ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 20, 2023
Project Management for Non-Project Managers – Forming, developing, and managing your project team
The subject of this webinar is building the project team. The key to achieving success with your project is the people you assign to it, how well you develop the team, and sustaining team members’ ongoing commitment to the successful completion of the project ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul