Training Doyens

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 In this webinar you will learn about the types of FDA inspections , preparations such as assigning personnel to specific tasks for the FDA inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and techniques for responding to 483s and warning letters. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them. WHY SHOULD YOU ATTEND FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483’s than a disorganized company.  If a 483 is received knowing how to respond will lessen chances of receiving an FDA warning letter. AREAS COVERED Personnel preparation Procedure to follow during FDA audits -what to do/ what not to do Facility ...

OVERVIEW Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the medical device design process, integrating it with the medical device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of use related hazards and risk analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document . WHY SHOULD YOU ATTEND The FDA will only approve devices which are designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly. The FDA has replaced the term “user error” with “use error”. This means that use error is considered by the FDA to be a device nonconformity because human factors should be considered in the design process. The burden is on the device designer to create an “idiot proof” product...

OVERVIEW While the FDA Food Safety Modernization Act(FSMA) rules for the sanitary transportation of human and animal foods require training for rail and road carrier transportation personnel, training is only the tip of the iceberg and does not certify carriers or shippers in food safety. The company’s responsibility under FSMA is to assure that there are transportation standards established, a plan is in place to document and meet the plan, the plan is verified, and there is some proof that the sanitation and temperature controls in place work to eliminate bacterial, chemical and physical contaminants in order to prevent food from becoming adulterated during transportation processes. For most companies, the deadline for plan development and implementation has passed. WHY SHOULD YOU ATTEND The deadlines for large company full compliance to the sanitary transportation rules has passed and April 6, 2018 is the final deadline for all “small” carriers of “food not completely ...

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...