FDA Compliance
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10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love
For a number of years now there has been an increasingly number of CGMP violations involving data integrity during CGMP inspections as observed by the FDA. One of the most important responsibilities of the industry is to ensure data... -
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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... -
21 CFR Part 11 Compliance for Electronic Records and Signatures
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11.... -
3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it... -
3 Hours Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
This seminar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps... -
3-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Aseptic techniques are used to create compounded sterile products. In Microbiological term; Aseptic technique refers to prevention of microorganism contamination. This activity is most important for successfully manufacturing safe and sterile therapeutics. Continuous cleaning, meticulous processing, sterile apparel and... -
3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit
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.This webinar will help you understand the FDA’s current thinking on computer... -
3-Hour Virtual Seminar on Complaint Handling and Medical Device Reporting and Recalls
Despite best efforts, serious quality issues resulting in a recall can occur. Medical Device companies need to be prepared in advance to handle the difficult situation. This 6-hour virtual seminar will prepare you to understand the signals that trigger... -
3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start... -
3-Hour Virtual Seminar on Death by CAPA – Does your CAPA Program need a CAPA?
This virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and... -
3-Hour Virtual Seminar on Effective Cleaning Validation Procedures – Best Practices
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as,... -
3-Hour Virtual Seminar on Ensuring Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists
Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors. Any violations from the vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor....
