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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
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
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
Technical Writing Training
Provides in-depth training in a highly specialized field Learn strategies that can be applied such that this training is not overwhelming Train Technical Writers in general guidelines for the creation and maintenance of documents Training for Technical Wr ...
- Basic & Intermediate
- 60 Mins
- Robert Peoples
- May 15, 2019
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 ...
- Basic & Intermediate
- 60 Mins
- Robert Peoples
- Jun 04, 2019
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented w ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Jun 05, 2019
Effective Batch Record Review
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Jun 11, 2019
Post marketing responsibilities for pharmacovigilance in the European Union (EU)
There is comprehensive regulation around the safety of medicines in the EU and marketing authorization holders have extensive responsibilities in this area for the drugs they market. The presentation will provide information on the requirements for pharmacov ...
- Intermediate
- 90 Mins
- Janet Jepras
- Jun 18, 2019