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Standadardizing Operations to Eliminate Human Error Potential in Life Sciences Operations
Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrence in pharmaceutical manufacturing. It occurs even ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Mar 19, 2019
Risk Based Approach to Auditing Quality Suppliers and Vendors
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implem ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Mar 19, 2019
Technical Writing: Best Practices
Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. The term is primarily associated with the pharmaceutical and medical devices industries but applies to documents creat ...
- Basic
- 60 Mins
- Robert Peoples
- Mar 27, 2019
Knock, Knock, Who’s There? Preparing for an FDA Inspection
Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage i ...
- Intermediate
- 90 Mins
- Susanne Manz
- Apr 02, 2019
Steam Sterilization Microbiology and Autoclave Performance Qualification
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization proc ...
- Basic & Advanced
- 60 Mins
- Danielle Delucy
- Apr 02, 2019
New GCP Compliance Requirements for Clinical QMS
Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based. Reg ...
- Basic & Intermediate
- 60 Mins
- Laura Brown
- Apr 02, 2019
Writing Validation Master Plans:Best Practices for Writing a Compliant Document
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective guidelines for authori ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Apr 03, 2019
Validation of Complex Cell-Based Potency Methods
This webinar will address development and validation of complex cell-based methods some cell-based methods are multifaceted Will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, Will also discu ...
- Basic & Intermediate
- 60 Mins
- Gwen Wise-Black
- Apr 04, 2019
21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Apr 10, 2019
How to Author an Effective 483 and Warning Letter Response
This course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Additionally, this course will review ...
- Intermediate
- 90 Mins
- Kelly Thomas
- Apr 10, 2019