Training Doyens

OVERVIEW The FDA has provided two guidance documents on software and device changes, which provide information as to whether a new 510(k) is needed. The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers evaluate whether a new 510(k) is required . Examples of device changes and recommendations for documenting a company’s decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:      • Labeling      • Technology, engineering, performance and materials for in vitro diagnostic devices The second FDA guidance addresses proposed changes to software used in conjunction with a medical device. The guidance includes modifications made to correct software defects, provide patches or updates to code, and provide ...

OVERVIEW 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. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on System Development Life Cycle (SDLC) Methodologies. The webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards .  You will learn about what must be done to ensure the system remains in a validated state.  In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process. WHY SHOULD YOU ATTEND This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodologies when validating computer systems subject to FDA regulato...

A distinctly different consulting approach to advance your business interests. Our consulting services include: (A) Consulting  - Quality Systems | Regulatory Audits | GMP Trainings Quality systems Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. Regulatory Audits We design audit and corrective action plans to accommodate our client's needs, including MHRA, EMEA, and FDA regulations. During our audit process, we evaluate your existing quality systems, and provide an exact assessment on the company's various systems. We then recommend a plan of cor...

Carolyn Troiano Carolyn Troiano FDA Compliance Consultant Years of Experience:  35+ years Areas of Expertise:  Strategic Planning, Project Management, FDA Regulatory Compliance, Organizational Development & Effectiveness, and Change Leadership & Management Carolyn Troiano  has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution. During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the...

OVERVIEW This webinar will take you through the  System Development Life Cycle (SDLC)  approach to  Computer System Validation (CSV) , focusing on the definition, testing, and documentation of functional and other requirements to ensure the system meets FDA compliance. This FDA compliance training will help you understand how the definition of functional and other system requirements fit into the  System Development Life Cycle (SDLC)  approach to  Computer System Validation (CSV) . Getting the requirements right, and ensuring they are comprehensive, is one of the most challenging components of the process. WHY SHOULD YOU ATTEND You should attend this webinar to learn about: Computer System Validation (CSV) approach. Using the System Development Life Cycle (SDLC) methodology to support CSV efforts. CSV and SDLC deliverables that must be documented properly to comply with FDA requirements. A deeper dive into ...

OVERVIEW FDA requires that all documentation related to GxP (GMP, GLC, GCP) products be created and maintained in accordance with specific rules. From the color of the ink used to the FDA labeling requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation. The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the validation deliverables for computer systems regulated by FDA and how to document them through the entire process. WHY SHOULD YOU ATTEND You should attend this webinar if you are responsible for any FDA-regulated data and/or records.  All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit.  You will also benefit from learning about the guidelines...

OVERVIEW This Computer System Validation Training 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 updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters. Computer System Validation WHY SHOULD YOU ATTEND Upon completing this course participants should: Understand what is expected in Part 11 and Annex 11 inspections How to avoid 483s and Warning Letters How to implement a computer system u...