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Audit Principles and Practice
GW 502 – This module offers an overview of FDA audits. It includes an overview of the FDA Bioresearch Monitoring Program, types of FDA inspections, inspection reports and classifications, common FDA audit findings and the investigator disqualification process.
Auditing Techniques
GW 1700 – This module offers an in-depth review on auditing techniques. It includes information on logistics & planning, tools & trackers, audit methods, interviewing strategies, conducting summary meetings and how to report findings.
Common Deficiencies and FAQs for FDA Audits
GW 324 – This module gives a broad range of deficiencies found in FDA audits (informed consent, protocol non-adherence,inadequate/inaccurate records, inadequate product accountability) as well as answers to many frequently asked questions.
Developing SOPs
GW 54 – This module offers information on how to develop SOPs from planning stages through implementation. It includes how to comply with Title 21 CFR, meeting ICH guidelines, how to comply with individual institutional policies and precedures and SOP implementation.
FDA Audit Principles and Practice
GW 372 – This module offers information on FDA audit principles. It includes information on the FDA Bioresearch Monitoring Program, types of FDA inspections, common audit findings, how to prepare a site for an FDA audit, how to respond to warning letters and how to set up an FDA audit plan.
FDA Bioresearch Monitoring Program
GW 652 – This module offers an overview of the FDA Bioresearch Monitoring Program and includes types of inspections, inspection reports and classifications, common inspection findings and the investigator disqualification process.
Implementing SOPs
GW 56 – This module offers practical advice on the implementation of SOPs and how to get management and staff buy-in for the new procedures, as well as, training techniques and the importance of SOP documentation.
Meeting the Challenges of Implementing SOPs for Clinical Research
GW 317 – This one hour module offers an understanding of how to meet challenges one is faced with when implementing SOPs for clinical research. It includes information on how to get management and staff buy-in to new procedures, training techniques and the importance of documentation.
Special Considerations: Customizing SOPs
GW 55 – This module offers in-depth information on how to customize SOPs. It includes navigating your way through SOPs in a changing regulatory environment, evaluating current SOPs and deciding which ones are needed and when and how to update SOPs.
Standard Operating Procedures for the Investigative Site
GW 399 – This half day course includes information on setting up and maintaining SOPs at the investigative site. It includes how to write SOPs that are current with regulatory requirements, how to customize SOPs for your individual needs and how to implement SOPs and get staff buy-in.
Course Registration and Pricing
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