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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
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
Risk management Planning in the EU
A medicine is authorized on the basis that its benefits outweigh its risks for the target population. However, not all potential or actual adverse reactions are identified by the time an initial marketing authorization is granted. The aim of risk management is ...
- Intermediate
- 90 Mins
- Janet Jepras
- 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
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
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
Quality Risk Management Overview
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions In addition they will b ...
- Basic & Advanced
- 60 Mins
- Steven Laurenz
- 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
Assessment of Drug Interactions in Drug Development
Drug-drug interactions are a common problem and result in hospital admissions for medically important and even fatal adverse events. Drug-drug interactions can also cause partial or complete abolishment of treatment efficacy. The ageing population, where p ...
- Basic
- 60 Mins
- Stefano Persian
- May 08, 2019
Adopting Price Controls for U.S. Prescription Drugs: Federal Policy Outlook for 2019 & Beyond
The cost of prescription drugs in the United States remains a hot-button issue for policymakers and consumers alike The vast majority of the public sees drug prices as unreasonably high with one in four people taking prescription drugs reporting difficulty ...
- Basic & Intermediate
- 60 Mins
- Dennis Weissman
- May 09, 2019