Search Trainings
21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA
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 the development of a company philosophy and approa ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jan 19, 2021
Remote Auditing During a Global Pandemic
Internal Audit and Supplier Audits are essential for medical device companies to self-identify and mitigate risks. The COVID19 pandemic has made this important task even more difficult due to travel restrictions. This webinar will provide insights into how to ...
- Basic & Intermediate
- 60 Mins
- Susanne Manz
- Jan 19, 2021
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...
- Basic & Intermediate
- 90 Mins
- David Nettleton
- Jan 19, 2021
A Verification and Validation Program to Meet US FDA and EU MDR / ISO Requirements
Review a company's Verification and Validation Program for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. Address the lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating it ...
- Intermediate
- 60 Mins
- John E. Lincoln
- Jan 20, 2021
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a ...
- Intermediate
- 60 Mins
- Roger Cowan
- Jan 20, 2021
Corrective and Preventive Action (CAPA)- Principles of Lean Documents and Lean Configuration
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" ...
- Intermediate
- 90 Mins
- José Mora
- Jan 21, 2021
Billing with Modifiers
Modifiers are used to describe specific situations for claims processing of medical claims. Insurance carriers expect to see modifiers in certain scenarios based on their policies as well as guidelines from the American Medical Association, Medicare, and speci ...
- Intermediate
- 60 Mins
- Lynn Anderanin
- Jan 26, 2021
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Computer system validation has been regulated by the 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. ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Feb 04, 2021
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 23, 2021
Proper CAPA Management
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...
- Intermediate
- 60 Mins
- Danielle Delucy