Search Trainings
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jul 18, 2019
Compliance for Risk Based Approaches for clinical trials including the New FDA RBM Guidance 2019
Risk management is becoming increasingly important for running clinical trials. There are now numerous pharmaceutical guidelines covering risk assessment and management and Risk-Based Monitoring (RBM) including the revised ICH GCP R2 guideline, EU Clinical Tri ...
- Basic & Intermediate
- 60 Mins
- Laura Brown
- Jul 18, 2019
Secrets to Writing Effective SOPs
Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures.This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective.You will learn techniques for creati ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Jul 24, 2019
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Jul 24, 2019
Current Trends in Cyber security Threats for Medical Devices
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Aug 06, 2019
Advertising and Promotional material compliance and review process
The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, stra ...
- Basic & Intermediate
- 90 Mins
- Peggy J.Berry
- Aug 21, 2019
Medical Device Cyber-security following latest FDA Guidance
The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market.The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communi ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reac ...
- Basic & Intermediate
- 90 Mins
- Michael Esposit
Effective Standard Operating Procedure (SOPs) Development
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
FDA Internal Complaint Handling
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages.The webinar will address aspects of the review process, SOP p ...
- Intermediate
- 90 Mins
- Peggy J.Berry