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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 development of a company philosophy and approach, ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jul 09, 2020
Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Jul 14, 2020
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
- Jul 16, 2020
ETHICS: BEST PRACTICES AND DECISION MAKING
This webcast is intended to discuss with professionals the importance of ethics in all our business relationships and in the performance of our duties. We will look at what “ethics” is and discuss processes, procedures, and controls we can use to maintain our ...
- Basic & Advanced
- 60 Mins
- Candace Leuck
- Jul 17, 2020
Content and Format of an Initial IND submission 21 CFR 312.23
This webinar is designed to help pharma companies through the content and format of every module of the common technical document for an initial IND. The presentation will cover the in depth understanding of the contents of every module in the CTD.
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Jul 21, 2020
European Union Device Regulation (EU MDR)
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...
- Intermediate
- 60 Mins
- Edwin Waldbusse
- Jul 22, 2020
Project Management Tools for Regulatory Compliance
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time. It w ...
- Intermediate
- 60 Mins
- John E. Lincoln
- Jul 28, 2020
Instrumental Issues in GC and GC-MS for On-Going Validation
Instrumental gas chromatography as an analysis is widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation ...
- Intermediate
- 60 Mins
- John Fetzer
- Jul 28, 2020
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
- Jul 29, 2020
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jul 30, 2020