Clinical & Laboratory
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Bringing Risk Based processes into your SDLC
Risk Assessment is now an underlying principle in global regulatory compliance, appearing in both governmental, i.e., FDA, EMA and non-governmental standards such as ISO. Gain an understanding of how, when and where to apply risk assessments to IT compliance... -
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Building a Compliant Documentation and Training System
This 60 minutes webinar will give a better understanding of the relationship between compliance, documentation, and training. It will provide participants with the ability to effectively meet regulatory requirements, properly integrate training into their quality system, and develop effective... -
Building QbD and RBQM Systems into Clinical Operations
This session is focused on Quality by Design (QbD) and new regulatory requirements for Risk-Based monitoring and building Risk-Based Quality Management (RBQM) systems. Besides being a new expectation by regulatory agencies under good clinical practices, Quality by Design (QbD)... -
Calculations for Process and Product Capability
Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees... -
Calibration and Qualification in Analytical Laboratories
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product... -
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
When there is a need to make some change to an environment and/or resolve a problem, we must think about a project that could implement the necessary change and address the problem. But we can’t just run our project... -
cGMP Water Systems – Are You Ready for the FDA Inspection?
All Pharmaceutical products and R & D require USP and FDA Pharmaceutical Grades of Water. It is used as an ingredient, cleaning manufacturing equipment, a key ingredient for Quality tests and sold in containers. If a company cannot meet,... -
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Cleaning Validations Using Extraction Techniques
Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has... -
Clinical Project Management
GCPs are required to be followed during conduct of clinical trials; it is the responsibility of the sponsor to ensure that all aspects of the study comply with legal and regulatory requirements to ensure integrity and reliability of the... -
Clinical Quality Auditing
As defined, Clinical Quality Audit is the process for improving the overall quality standard of clinical performances against the established standards. To evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements auditing needs to be... -
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Clinical Trials for The Intended Use of Software as a Medical Device
The FDA regulates standalone software as a medical device (SaMD) that is used for medical treatment or diagnostic applications. The clinical impact and corresponding risk associated with the use SaMS must incorporate a number of cross matching factors. Applying... -
CMO Supplier Quality Agreements – How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture
A contract between a GMP Contract Manufacturer and a pharmaceutical firm is a Quality Agreement and it details responsibilities of both parties by assuring the safety, efficacy and quality of the drug that has been manufactured. Recently FDA and... -
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Comparing GLP with GMP
Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also significant differences. There are many questions about the differences... -
Complaint Handling – Best Practices
This webinar will provide approaches to setting up an internal complaint handling system that ensures compliance with all GMP requirements. The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during...