All FDA Regulated Industry
Next Steps for Industry After COVID-19, The New Endemic Normal
The COVID-19 crisis has brought extraordinary strains to business practices and complicated supply chains to provide goods to consumers. Organizations should safeguard to ensure protocols to manage during the prolonged pandemic are in place for the long-haul, while managing food safety needs. Areas Covered Identifying concerns and risksPandemic planning- Remote workforce- Reopening business- Frontline emplo..
How to Deal With Difficult Customer Effectively
Difficult customers can be much more than just an occasional irritation. They can damage the reputation of a laboratory, take up a lot more time than the average customer, and can disrupt operations. Difficult customers are varied in how they deal with problems and the laboratory. Inter-personal skills in speaking, listening, negotiating, and other areas are needs that fall outside of the skill set of the l..
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommendations to assure that in addition to being able to illustrate compliance, your firm’s CAPA system is useful and meaningful.CAPA is the most cross-..
Risk Assessment tools and Techniques in the Medical Device Industry
Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory ..
Medical Device Software and FDA Compliance
FDA requires that all computer systems used to produce, manage, and report data for “GxP” (GMP, GLC, 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..
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..
Auditing for Microbiological Aspects in Pharmaceutical Manufacturing
The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing fa..
Effective Design of Experiments (DOE) Strategies
The effective and progressive use of a Screening DOE, a Mapping DOE and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum. NOTE: This webinar focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.This DOE (Design of experiments) training fo..
Sample Size Selection
Mr. Yuval Shapiro shall review the basic statistics that is behind the Sample Size selection. Explanations on how to select samples for design (verification and validation) phase, and for production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Areas Covered What is Sample Size and why is it important?Power AnalysisEstimation, Accuracy, PrecisionHypo..
FDA Inspection Readiness Dos and Don’ts
The Food, Drug and Cosmetic (FD&C) Act gives FDA the authority to conduct inspections at drug and medical device manufacturing facilities as well as other regulated industries. Those companies manufacturing drugs and higher risk medical devices, are prime candidates for inspections. Facilities having historical significant violations, are also FDA inspected. Areas Covered The inspection process – what t..
C-TPAT Compliance for FDA Regulated Industries
The market for counterfeit and contraband or “pirated” products can be divided into two important areas. The primary market provides consumers with counterfeit and contraband products. These consumers believe they have purchased genuine products. However, these products are often below standard and can result in health and safety risks that range from mild to life-threatening. The secondary market provides ..
FDA Aseptic Guidance
Aseptically processing the final drug product is a crucial step in the drug manufacturing process. Failures related to the aseptic processing of a final drug product are detrimental to patients. In many cases, once a failure is discovered, the drug product is considered unfit for use and may be destroyed. By understanding and implementing the concepts described in the Aseptic Guidance document– Sep 2004, ma..
Through the Eyes of an Auditor
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for.Anyone in a medical device set..
Proper Execution of Annual Product Reviews
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize product defects and also the risks associated with the manufacturing of the pharmaceutical product.Learning..
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 th..