Clinical Trial and Clinical Research
Sampling by Variables (ANSI/ASQ Z1.9, formerly MIL-STD 414)
ANSI/ASQ Z1.9 (formerly MIL-STD 414) is an acceptance sampling plan that uses the average measurement of a sample, and its range or standard deviation, to determine whether a production lot should be accepted. This webinar will show how to select and use sample plans.Attendees will receive a pdf copy of the slides and accompanying notes, and an Excel spreadsheet that converts a traditional sampling plan i..
Basics of Clinical Trials
Useful for those entering the pharma industry or academics to understand how clinical trials are conducted. The study objectives, endpoints, entry criteria, study visits, evaluations, safety assessments, statistical considerations, manufacturing and compound supply, and regulatory considerations. The design of randomized, placebo studies can be open-label or blinded (single, double, or triple-blinded). ..
Narrow Limit Gauging
Narrow limit gauging, which relies on tightened acceptance limits to assess the quality of a sample, can enormously reduce the required sample size and therefore the cost of inspection. This webinar will equip attendees to convert any ANSI/ASQ Z1.4 (formerly MIL-STD 105) sampling plan into a narrow limit gauging plan.Learning Objectives A review of the basics of ANSI/ASQ Z1.4. A major takeaway is..
Clinical Sample Analysis: Considerations for the Bioanalytical Lab
Reviews the history of the GCPs from Tuskegee to Nuremberg, Helsinki to the current 21 CFR and other protections, demonstrating the evolution of the regulation's current status. Particular focus will be on constraints, including requirements for informed consent and the disposition of samples. Several illustrations of recent violations will be provided, along with the consequences. Areas CoveredEvolution of..
Digital Phenotypes, Digital Twins, and N of 1 Data in the Design of Personalized Measurement-based Clinical Care
The technology currently available for quantifying various biometric, behavioral, emotional, cognitive, and psychological aspects of daily life has become increasingly diverse, accurate, and accessible, with ongoing and continuous improvements. These burgeoning technologies can and will profoundly alter the way lifestyle, health, wellness, and chronic diseases are managed in the future. For those pursuing t..
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..
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..
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..
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
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
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
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
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
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..
Auditing Quality Suppliers and Vendors
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Learning Obj..