Medical Devices
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6-Hour Virtual Seminar on Statistics for Quality Control
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical quality control: obtaining information... -
A Bulletproof, Cost-Efficient Supplier Management Program
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company’s purchasing and supplier control requirements provide the assurance... -
A to Z of Supplier Management in the Medical Device Industry
Supplier management is an integral part of any quality system in regulated industries. Quality System regulation (QSR) and ISO 13485 have specific supplier management requirements that you are answerable to. FDA is getting more rigid about supplier audits and... -
Achieving Compliance with Proper CAPA Systems
This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects... -
Additive / 3D Printing Manufacturing and Its Regulatory Issues
Additive Manufacturing (AM) or 3D Printing for manufacturing of medical devices is a new and rapidly expanding field, with rapidly expanding regulatory concerns. What is it? What are US FDA stated concerns? This webinar will focus on the key... -
Adequate 510(k) Preparation Could Save Significant Resources – Dos and Don’ts
This seminar is intended to help medical device industry exercise best judgment when preparing for premarket notification for submission to the FDA. This webinar will provide great opportunities to get familiar with FDA policy and guidelines on how... -
Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks
Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. This training program will teach attendees best practices on how to perform audits for data integrity within their... -
Advertising and Promotional Material Compliance and Review Process
The webinar will address requirements for compliance, “gray areas,” risk assessment, opportunities for input from regulatory agencies, and review process and procedures. This webinar will address issues of compliance in the creation of advertising and promotional materials and the... -
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... -
Applying Computer System Validation to Mobile Applications
Mobile applications can be validated as per FDA regulations using the same principles of computer system validation. For this to be compliant, development of an appropriate validation strategy to achieve the diligence required to prove that a system does... -
Artificial Intelligence (AI) Algorithms as Medical Devices – Regulatory Requirements
This webinar will discuss the impact of incorporating Artificial Intelligence based algorithm on the premarket regulatory requirements from medical devices and healthcare products. The regulatory requirements associated with AI based software as medical device products will be mapped and... -
Artificial Intelligence in Pharmaceutical GMP Operations – Case Studies
This latest webinar will showcase possibilities with some case study examples of what can be done. The case study for manufacturing, maintenance, instrumentation, Quality assurance and regulatory assurance functions will be discussed. It is a must attend webinar to... -
Aseptic Process Overview 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... -
Aseptic Processing and Techniques 101
Many of the drug products manufactured for use are injected into our bodies. By avoiding our first line of defense against infection, any possible source of infection can wreak havoc on our immune systems. In order in insure our... -
Auditing 101
The Course clarifies the role of the new auditor or internal auditor and explains their responsibilities. The session will also discuss interactions with others in key roles as part of the audit as well as exploring some techniques used... -
Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach
This training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities...
