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Validity : 26th Sep'23 to 06th Oct'23
Search Trainings
Recorded Webinar
Data Integrity 21 CFR Part 11 Training
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
Recorded Webinar
Vendor Audit for Systems and Services for FDA-Regulated Systems
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
Recorded Webinar
Current GXP expectations on Water system validation compliance
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...
- Basic & Intermediate
- 90 Mins
- Hitendra Kumar
Recorded Webinar
Best Practices in Preparation for an FDA Audit of Regulated Computer Systems
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 sys ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
Recorded Webinar
Writing Effective SOPs for QMS in the Pharmaceutical and Medical Device Industries
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.More importantly,well writt ...
- Basic & Intermediate
- 60 Mins
- Carl Patterson
Recorded Webinar
Design Traceability Matrix - Principles of Lean Documents and Lean Configuration
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design ...
- Basic & Intermediate
- 90 Mins
- José Mora
Recorded Webinar
Cloud and Software-as-a-Service (SaaS) Vendors: Approach to Validation for FDA-Regulated System
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. Th ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
Recorded Webinar
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test ...
- Basic & Intermediate
- 90 Mins
- José Mora
Recorded Webinar
An Advanced Course on Lean Documents, Lean Configuration, and Document Control
In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...
- Basic & Intermediate
- 90 Mins
- José Mora
Recorded Webinar
Human Factors / Usability Studies following ISO 62366 the FDA Guidance and the new FDA Draft Guidance
Human Factors/ Usability is the analysis of how users interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the eff ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse