Search Trainings
Investigating OOS results
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...
- Basic
- 60 Mins
- Danielle Delucy
- Apr 23, 2019
CAPA Under U.S. FDA / CGMPs and EU MDR / ISO
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus.The roles of Failure Investigation a ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Apr 24, 2019
Process Validation for Drugs and Biologics
This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. Attendees will learn how to establish an effective process validation system and inte ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- May 02, 2019
Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?
This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.
- Intermediate
- 90 Mins
- Peggy J.Berry
- May 03, 2019
Six Capabilities Necessary for an Effective and Efficient Quality Management System
The quality management system can be improved by understanding these six essential capabilities.The webinar will highlight warning signs and maturity levels for these six capabilities. Once companies understand their level of maturity, they can create concrete ...
- Basic & Intermediate
- 60 Mins
- Susanne Manz
- May 07, 2019
Human Factors Validation Testing following ISO62366 and FDA Guidance
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quan ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
- May 07, 2019
21 CFR 111 GMP Dietary Supplement Laboratory
This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested It will futher review the test procedures and documentation requirements to ensure regulatory compliance ...
- Basic & Advanced
- 60 Mins
- Gwen Wise-Black
- May 07, 2019
Overview of FDA's Risk Evaluation and Mitigation Strategy (REMS)
Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- May 07, 2019
Writing World Class Compliance documentation – SOPs & Work Instructions
Standard Operating Procedures and Work Instructions – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- May 09, 2019
FDA Compliance Trends for Computer System Validation
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FDA’s current thinking on computer syste ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- May 15, 2019