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87 results of "Life Sciences x" and "Biotech & Biologics x"
Live Webinar

Medical Device Hazard analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a re ...

Live Webinar

Analytical Method Validation and Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for ...

Live Webinar

Risk Based Design Control Requirements and Industry Best Practices for Medical Devices

This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

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 ...

Recorded Webinar

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, ...

Recorded Webinar

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 ...

Recorded Webinar

Design Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs.  These design inputs then form the basis of the design specification, which becomes the design output.  Since design ...

Recorded Webinar

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role reversal between the test method and the product or process it is designed to detect.  For example, while a defect-free process is desirable, a test ...

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Validity : 29th May'23 to 08th Jun'23