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GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most im ...
- Intermediate
- 60 Mins
- Roger Cowan
- Feb 07, 2023
USING A SUPPLIER RATING SYSTEM
How do you know how well your suppliers are doing? Most responses present a subjective view. It is akin to throwing darts - sometimes you are close, but most times you are "off-target". You need a tool that will provide an objective, quantitative visibility ...
- Basic & Intermediate
- 75 Mins
- Michael Gozzo
- Feb 07, 2023
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most im ...
- Intermediate
- 60 Mins
- Roger Cowan
- Feb 07, 2023
Human Factors / Usability Studies following ISO 62366 the FDA Guidance and the new FDA Draft Guidance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
- Feb 13, 2023
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
- Feb 16, 2023
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
- Feb 23, 2023
Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulat ...
- Basic & Intermediate
- 90 Mins
- David Nettleton
- Feb 24, 2023
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
- Feb 24, 2023
SUPPLIER/VENDOR-MANAGED INVENTORY
Supplier/Vendor Managed Inventory is a program that optimizes supply chain performance. The supplier and the customer learn to operate in a mutually beneficial manner that provides financial gains as well. It is a process for resupplying inventory in an expe ...
- Basic & Intermediate
- 75 Mins
- Michael Gozzo
- Feb 27, 2023
Medical Device Trends in FDA Compliance and Enforcement
This webinar will focus on medical devices, a key concern for FDA as they become more and more complex, and require methodical risk assessment and mitigation. Protecting medical devices from hacking where someone can alter the actual code embedded in the devic ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 01, 2023