Clinical Trial and Clinical Research
![How to implement an effective Human Error Reduction Program How to implement an effective Human Error Reduction Program](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95%20-%20NEW%20IMAGE/Ginette%20Collazo%20(2)-80x90.jpg)
How to implement an effective Human Error Reduction Program
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. For example, The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of the quality control unit.” and it states that “(a) There shall be a qualit..
![Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/Carolyn%20Troiano-1-80x90.jpg)
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
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 jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evalua..
![Human error reduction in GMP manufacturing/floor Human error reduction in GMP manufacturing/floor](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95%20-%20NEW%20IMAGE/Ginette%20Collazo%20(2)-80x90.jpg)
Human error reduction in GMP manufacturing/floor
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall h..
![21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/Carolyn%20Troiano-1-80x90.jpg)
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.Areas CoveredCompu..
![Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/Carolyn%20Troiano-1-80x90.jpg)
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..
![FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/Carolyn%20Troiano-1-80x90.jpg)
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities
This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.Areas CoveredPros and cons of using social media venuesCompliant use of Social Media i..
![GMP for QC Laboratory Compliance GMP for QC Laboratory Compliance](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/KELLY%20THOMAS-80x90.png)
GMP for QC Laboratory Compliance
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect of manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements.Learning ObjectivesThe Good Manufacturing Practice Program provides a comprehensive overview of the best practices regarding the manageme..
![Implementing a Change Control Quality System Successfully Implementing a Change Control Quality System Successfully](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/Danielle%20DeLucy-80x90.png)
Implementing a Change Control Quality System Successfully
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..
![The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/John%20C.%20Fetzer-80x90.jpg)
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory
Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than ..
![2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance 2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/ANGELA%20BAZIGOS-80x90.jpeg)
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..
![21 CFR Part11 Compliance 21 CFR Part11 Compliance](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/EDWIN-WALDBUSSER-80x90.png)
21 CFR Part11 Compliance
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t..
![5S for Operators 5S for Operators](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/GINETTE_COLLAZO-80x90.png)
5S for Operators
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..
![Advertising and Promotional Material Compliance and Review Process Advertising and Promotional Material Compliance and Review Process](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/PEGGY_J_BERRY-80x90.png)
Advertising and Promotional Material Compliance and Review Process
The information obtained will enable the 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, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..
![An OSHA Inspection in the Laboratory An OSHA Inspection in the Laboratory](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/DAN%20SCUNGIO-80x90.jpg)
An OSHA Inspection in the Laboratory
Do you know why OSHA would come to your lab? Do you know how to respond to an OSHA complaint or allegation? Join Dan the Lab safety Man as he discusses the steps to prepare your lab for an OSHA visit and how to properly respond when it actually happens.Areas CoveredReview the steps in OSHA’s inspection processDiscuss areas in the laboratory where potential OSHA violations are likelyCalculate possible fines ..
![Auditing Basics and Fundamentals for Medical Devices and Drugs Auditing Basics and Fundamentals for Medical Devices and Drugs](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/FRANK_POKROP-80x90.png)
Auditing Basics and Fundamentals for Medical Devices and Drugs
Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundamental tool of risk management. The auditor assures alignment with prescribed practices and is at the front line in evaluating control systems, testing, measurement and more. Auditors asses the acc..