On Demand Webinars
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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 Validation and Part 11 Compliance of Computer Systems
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an... -
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... -
Recording
3-Hours Virtual Seminar – Technical Writing for the Regulated Industries
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such... -
Recording
4 Hours Virtual Seminar – Change Control According to GxP and GMP Requirements
Pharmaceutical and medical device companies are required by regulatory agencies to have a systematic approach especially when it comes to managing all changes made to a facility, the product or the quality system. Change is inevitable; however, it is... -
Recording
4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Electronic record/electronic signature (ER/ES) capabilities are extremely important and should be built into FDA-regulated computer systems to meets compliance with 21 CFR Part 11. This webinar will help you to strategize the development of a company philosophy and approach,... -
Recording
4-Hour Virtual Seminar on Analytical Instrument Qualification and Validation – Understanding Use of Excel and FDA Audit Preparation
Global agencies across the world have varied expectations of analytical equipment qualification which will be discussed in this webinar. You will also learn how to develop a sound process validation program in order to implement invulnerable solutions that are... -
Recording
4-Hour Virtual Seminar on Aseptic Processing and Validation
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a... -
Recording
4-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Aseptic techniques are used to create compounded sterile products. In Microbiological term; Aseptic technique refers to prevention of microorganism contamination. This activity is most important for successfully manufacturing safe and sterile therapeutics. Continuous cleaning, meticulous processing, sterile apparel and...
