All FDA Regulated Industry
COTS, Cloud, and SaaS Systems and FDA Validation Compliance
“How can we perform an Installation Qualification (IQ) when the server is completely under the control of a vendor?”“How do we know the vendor will be able to manage security, backups, disaster recovery, and other aspects required to ensure data is collected and maintained with integrity?”“What about change control?”“How will we handle compliance with 21 CFR Part 11, FDA’s guidance for electronic records an..
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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..
Applying Risk-based Approaches to Processes Under the Quality Management System
Just about every process in the QMS can be driven through risk-based thinking. Creating a simple and effective plan is key to a successful application. This discussion will outline specific proven approaches to specific processes, ensuring both a rigorous approach and one that is acceptable to auditors/inspectors.Areas Covered The “big” ones: purchasing, training, computer system validationOthers: Aud..
Training Requirements and Practices to Assure QSR and ISO Compliance
A complete and effective employee training program must be in place to assure training requirements are established, implemented, and verified. This session will instruct attendees on the regulatory requirements of personnel training, and the establishment of a training program, including new employee training, methods of training, and how to document training so that it is readily available for review (by ..
How do you use FDA Guidance Documents and Recognized Standards – Perspective of a Consultant?
This event will help you to learn about the FDA’s Guidance Documents and their recognition of standards. The FDA is the regulator for medical devices, and they want to ensure products are safe and effective. An optimal way of doing so is through the use of standards. Standards are developed by a cross-section of personnel from clinical and technical areas. The FDA is one of those stakeholders which allows t..
101_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..
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the ..
FDA Finally Outlaws Soda Ingredient Banned Around the World
For several decades, vegetable oils have been touted as healthy and the use of a brominated vegetable oil (BVO) as an ingredient would not normally have raised any concerns. BVO is a vegetable oil that is modified with bromine. Up to now, its use has been authorized by the FDA in small amounts to keep the citrus flavoring from separating and floating to the top of some beverages.Dietary supplements and food..
Good Documentation Practice and Record Keeping Regulations (FDA and EMA)
Good documentation Practices (GDP) are an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules an..
Regulatory Strategy in The Pharmaceutical Industry: Paving the Way From Concept to Commercialization
Regulatory strategy in the pharmaceutical industry refers to the plan put in place by a pharmaceutical company to ensure compliance with laws, regulations, and guidelines set forth by regulatory agencies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe or any other relevant drug regulatory authorities.Some key components of a successful reg..
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..
5 Key Components of Good Manufacturing Practices to obtain cGMP certification
Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilities to meet the standards for a product to be deemed safe, pure, and effective. Good Manufacturing Practices are critical to any organization that produces products for the public. This training will discus..
Analytical Method Validation and Transfer
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of thi..
Basic Validation Statistics for Non - Statisticians
In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the c..
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures
21 CFR Part 11 was promulgated in 1979 to address a gaping hole in the regulations regarding the use of electronic records and electronic signatures. The rule was, by FDA’s admission later, confusing and challenging. Learning ObjectivesOverview of 21 CFR Part 11Explain the concepts and rationale behind the rulesDiscuss the practical application of the rule Consider challenges with the ruleWho Sh..