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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
Investigating OOS results
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor, and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the step ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Apr 06, 2023
Vendor Audit for Systems and Services for FDA-Regulated Systems
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- 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
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
Training Effectiveness: How to develop instruments to measure learning and reduce errors
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the “vaccine for mistakes,” Training is as good as its ef ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- May 16, 2023
Design Control for Medical Devices Including Verification/Validation
Overview of design control for medical devices with and emphasis on verification and validation of design inputs. Webinar will cover basic regulations regarding verification/validation of inputs, trace of inputs to verification/validation and techniques includ ...
- Basic & Intermediate
- 90 Mins
- Alan M Golden
- Jun 05, 2023
Human Error and Management Systems: Designing Errors Out
If you work in the GMP regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Jun 14, 2023
An Advanced Course on Lean Documents, Lean Configuration, and Document Control
In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...
- Basic & Intermediate
- 90 Mins
- José Mora