Medical Devices
-
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... -
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... -
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... -
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... -
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... -
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... -
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,... -
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... -
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... -
4-Hour Virtual Seminar on Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong... -
4-Hour Virtual Seminar on Design and Conduct of Clinical Trials – Design Requirements, Statistical Issues, and Clinical Protocols
Clinical trials play a pivotal role in evidence-based medicine. This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical research. Topics will include basic principles and current methodologies used in the design, implementation, and... -
4-Hour Virtual Seminar on Design Control Program with Detailed Hazard Analysis, Human Factors and Software Discussions
US FDA believes that a device cannot be considered safe and effective unless the design has followed a rigorously controlled step by step process. This virtual seminar will teach you how to set up and maintain a process that... -
4-Hour Virtual Seminar on FDA Inspection Readiness – Be Ready!
Adverse findings during a FDA inspection depending on their severity can have catastrophic results to the company, the function targeted by the findings, and management. Every associate within the organization is responsible for being compliant and having the skill... -
4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) vs GMPs – Comparison and Contrasts
Nonclinical laboratory studies must comply with the Good Laboratory Practice (GLP) regulations prescribed in Title 21 CFR part 58. This has been crafted to ensure data quality and integrity. These studies support or are intended to support applications for... -
4-Hour Virtual Seminar on Project Management for Non-Project Managers
It is not possible to present a complete treatment of project management in the span of 3-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of... -
4-Hour Virtual Seminar on Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs
Computer system validation (CSV) relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA has been regulating CSV for more than 30 years now....
