FDA Compliance
-
Sale!
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation... -
ANDA Approval Process Pursuant to GDUFA
The regulatory requirements for generic drugs include, but not limited to, same active ingredients, same dosage form, same route of administration, same strength, and same conditions of use compared to brand name drug product (RLD: reference listed drug). In... -
Sale!
Are you ready for the next FDA inspection? – Inspection Readiness Preparation
Have you done everything you can to prepare for your next FDA Inspection? Do you have an SOP for Regulatory Inspections? Do your employees know what to do when they get that phone call from security or a receptionist?... -
Sale!
Avoid Reporting Cybersecurity Updates and Patches to the FDA
Is a cybersecurity patch or update a reportable event under the Reports of Corrections and Removals regulation? (21 CFR Part 806) The FDA issued a guidance document recently entitled, “Postmarket Management of Cybersecurity in Medical Devices.” It explains that... -
Sale!
Basic Requirements for IQ, OQ and PQ Quality Protocols
Current regulatory requirements state the need to prove equipment, systems and utilities are verified to perform their desired functions. This verification comes in the form of qualification protocols that verify proper installation, operation over its entire range, and acceptable... -
Best Practices in Preparation for an FDA Computer System Audit
The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and... -
Sale!
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and... -
Sale!
Building a Compliant Documentation and Training System
This 60 minutes webinar will give a better understanding of the relationship between compliance, documentation, and training. It will provide participants with the ability to effectively meet regulatory requirements, properly integrate training into their quality system, and develop effective... -
CE Marking in the EU – Latest Regulations
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). CE marking is required for many products. CE marks: Show that the manufacturer has checked that their products meet... -
Sale!
Cleaning Validations Using Extraction Techniques
Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has... -
Sale!
Cleaning Validations Using Extraction Techniques
Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has... -
Sale!
Clinical Trials for The Intended Use of Software as a Medical Device
The FDA regulates standalone software as a medical device (SaMD) that is used for medical treatment or diagnostic applications. The clinical impact and corresponding risk associated with the use SaMS must incorporate a number of cross matching factors. Applying...
