On Demand Webinars
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Recording
3-Hour Virtual Seminar on Master Validation Plan – The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971... -
Recording
3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
Recording
3-Hour Virtual Seminar on Multi-State Payroll Compliance
This seminar will review the state wage and hour laws along with how to apply them with the federal wage and hour laws. Determining taxation and proper reporting will be reviewing. Polices on multi state taxation and hands on... -
Recording
3-Hour Virtual Seminar on Off Label Promotion for Drugs and Medical Devices
FDA and industry have struggled for the past 10 years, with the question of how FDA can reconcile its mission to protect public health by ensuring that medical products distributed in the United States are safe and effective for... -
Recording
3-Hour Virtual Seminar on Process Validation for Drugs and Biologics
This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other... -
Recording
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization’s resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are... -
Recording
3-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries
Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and... -
Recording
3-Hour Virtual Seminar on Root Cause Analysis and Corrective Action
his seminar will teach attendees how to conduct and document a robust root cause investigation. The tools that will be taught are 5WHYs, Fishbone Diagram, Cause and Effects Matrix, IS/IS NOT and Fault Tree Diagrams. This course will teach... -
Recording
3-Hour Virtual Seminar on Root Cause Analysis for CAPA Investigations
To ensure an organization’s quality system has a system to identify product and quality issues; the FDA mandates establishing a process for Corrective and Preventive Action. Any effective CAPA system must include the identification, documentation and review of root... -
Recording
3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections
The European Medicines Agency’s (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine... -
Recording
3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions
This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities.... -
Recording
3-Hour Virtual Seminar on Successful Deviation Investigations
This seminar will help attendees with the fundamentals and best practices for investigating deviations. It will focus on using facts and objective evidence to arrive at root cause and CAPA. To accomplish successful deviation investigations this course will focus... -
Recording
3-Hour Virtual Seminar on Technical Training in Life Sciences
This seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory... -
Recording
3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union’s MDD TF/DD and... -
Recording
3-Hour Virtual Seminar on Workplace Investigations – Witnesses Interviews (SHRM & HRCI Accredited Course)
Many employers struggle to gather information during witness interviews in investigations. Many employees for a variety of reasons are reluctant to be involved and can be less than forthcoming. Friends of employees and those accused of an offense are... -
Recording
3-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could...
