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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
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
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
Top Process Validation Mistakes - And How to Avoid Them
Validation is an important element of the Quality System Regulations and ISO13485.This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes.You’ll learn t ...
- Intermediate
- 90 Mins
- Susanne Manz
- Aug 05, 2020
Ten Keys for Maximizing the Benefits of your Measurement Systems Assessments
The effective use of data to drive decision making requires adequate measurement systems. When interpreting data or the results of data analysis, we assume that data or results represent the process. However, excessive measurement error may result in inappropr ...
- Intermediate
- 90 Mins
- Steven Wachs
- Aug 10, 2020
Process Capability Assessment for Normal and Non-Normal Data
Companies must assure that their processes are capable of producing products and services that consistently meet customer specifications. This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for ...
- Intermediate
- 75 Mins
- Steven Wachs
- Aug 18, 2020
Technical Writing: A Detailed Process
Provides step-by-step instructions to produce excellent written presentations Learn how to balance between being precise enough to cover the subject matter yet general enough to apply to other locations and/or projects Learn how to deal with reviewers and ...
- Advanced
- 60 Mins
- Robert Peoples