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
Preventative Controls for Allergen Risk Mitigation Under FSMA
A five-layered approach to Allergen Management will be described, with latest approaches for cleaning, Validation, monitoring and Preventative Controls now required under FSMA (Food Safety Modernization Act) to incorporate in your Food Safety Plan. Insights fo ...
- Basic & Intermediate
- 60 Mins
- Gina Reo
- Apr 25, 2019
FDA Rules for Pharmaceutical Analytical Method Validation
FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they ...
- Intermediate
- 60 Mins
- Loren Gelber
- Apr 30, 2019
cGMP Water Systems – How to Avoid Their Typical Emergencies & Problems
Pharma cGMP Water Systems are very critical to the safe production of medicines for patients. Several Departments are required for continued High-Quality operations. These include Quality, Manufacturing, maintenance and Validation on a daily basis. This presen ...
- Intermediate
- 90 Mins
- Peter T. Vishto
- Apr 30, 2019
Compliance with the New ICH GCP Revision 2 Addendum – Know the How?
This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites. This will enable y ...
- Basic & Intermediate
- 60 Mins
- Laura Brown
- May 01, 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
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
- May 03, 2019
Quality Control of Microbiological Media, Reagents and Test Kits
During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits and reagents specifically applicable to microbiology laboratories to assess the acceptability of the performance of analytical mat ...
- Intermediate
- 60 Mins
- Michael Brodsky
- May 07, 2019