Manufacturing Skills

What common importer or customs broker mistakes get unwanted scrutiny from U.S. Customs and Border Protection? What are the smartest steps that an importer should take to avoid shipment delays, requests for delays, detentions, seizures, and penalties/liquidated damages? This webinar is unique because it will be delivered by a practicing attorney not only for his expertise with customs law compliance, but also a former officer with CBP.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/COMPLIANCE-SECRETS-FORMER-CUSTOMS-OFFICER-502190/JULY-2017-ES-TRAININGREGISTRY

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/PHARMACEUTICAL-QUALITY-RISK-MANAGEMENT-506610/JULY-2017-ES-TRAININGREGISTRY

This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization's performance specifically related to equipment, processes and documentation.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/AUDITING-QUALIFYING-SUPPLIERS-VENDORS-504232/JULY-2017-ES-TRAININGREGISTRY

Changes in technologies and supply-chain arrangements have coincided with the expansion of regulations and standards to the entire supply chain. Unfortunately, many suppliers have not kept up or find themselves in a strange new world. It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations and requirements.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/QUALITY-MANAGEMENT-LEAN-DOCUMENTS-CONFIGURATION-504115/JULY-2017-ES-TRAININGREGISTRY

Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/EXCEL-SPREADSHEETS-502490/JULY-2017-ES-TRAININGREGISTRY

Product Reliability requirements must be satisfied like all other performance requirements prior to product launch. However, since reliability is a function of time, the methods for verifying that reliability performance has been verified differ than for most other performance characteristics. This webinar will present several approaches for verifying that reliability targets or specifications have been achieved at the desired level of confidence. Specifically, approaches using time-to-failure data to estimate reliability metrics as well as demonstration tests, where minimum reliability may be demonstrated with zero or few failures are discussed.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/DEMONSTRATING-PRODUCT-RELIABILITY-508137/JULY-2017-ES-TRAININGREGISTRY

This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/GOOD-DESIGN-HISTORY-FILE-AUDIT-506688/JULY-2017-ES-TRAININGREGISTRY

In many countries around the globe, certain medicines with a long history of use are allowed to be sold over the counter (OTC) at certain doses without a prescription. So the safety and efficacy are well known from a public health/patient safety perspective, a contaminated OTC medicine could potentially impact a larger user population than a prescription medicine.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/PRESCRIPTION-GMPs-FDA-FORM-483-506801/JUNE-2017-ES-TRAININGREGISTRY

Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/AUDITING-DATA-INTEGRITY-RISKS-509850/JUNE-2017-ES-TRAININGREGISTRY

Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. These cleaning processes may include initial cleaning validations, in process cleaning validations, or reprocess cleaning validations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CLEANING-VALIDATIONS-EXTRACTION-TECHNIQUES-503258/JUNE-2017-ES-TRAININGREGISTRY

This presentation provides a framework for understanding, managing, and reporting adverse events to the FDA. It uses plain English to describe the regulatory requirements as well as common quality tools such as flow diagrams and fault tree analysis. This approach helps participants understand and implement the essential parts of the regulations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/COMPLAINTS-SERVICING-FDA-REPORTING-507863/JUNE-2017-ES-TRAININGREGISTRY

This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/IQ-OQ-PQ-VERIFICATION-VALIDATION-PROCESS-503654/JUNE-2017-ES-TRAININGREGISTRY

Click on the name of the course to be taken to our website for class schedule, class outline, and to register. Students are taught how to create a process map to help enable them to identify problems with a particular MRO line. The class then takes an extensive look at forecasting to provide students with an understanding of industry recommended procedures for reliable forecasting. Next, we examine best practices in sales and operations planning and planning and scheduling in an MRO environment. We now discuss best practices in materials resource planning (MRP), capacity management, and production activity control to learn how to make the most of what we have to work with. The class moves on to training in lean manufacturing, just in time (JIT), and the theory of constraints. The class finishes with a discussion of the latest MRO planning software and technologies. Cost of this course is $1,999.00

Click on the name of the course to be taken to our website for class schedule, class outline, and to register. Every company has some degree of dysfunction. This course is designed to reduce dysfunction within manufacturing companies. Since its inception in 2010, the staff of the Academy of Business Training has worked with hundreds of manufacturing and MRO companies to improve their operations. Management of these companies experiences a myriad of problems with production and/or the MRO operation and assumes that’s what needs to be fixed. Therefore, many companies first exposure to us is our Production Planning, Scheduling, and Control course. What our instructors have learned in discussions held during class is most manufacturing and MRO companies are dysfunctional in that the various departments do not work as a team.

This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks.

This webinar discusses the steps to set-up a stability study and analyze the results to estimate the product's shelf life. The use of regression models to model the relationship between the response variable(s) and time are presented. Models useful for describing non-linear degradation over time are also presented. Additionally, methods for handling non-normal response data are also discussed. Finally, the use of accelerating variables to shorten the study time and the models required are introduced. The webinar includes several examples to illustrate the methods discussed.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/STABILITY-STUDIES-ESTIMATING-SHELF-LIFE-508052/MAY-2017-ES-TRAININGREGISTRY

This webinar will utilize ISO 19011:2011, ICH Q10 and FDA guidances and explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program, an overview of various cGMP regulations and how to reinforce their quality system, along with potential efficiency enhancements.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ISO-19011-2011-INTERNAL-AUDITS-505127/MAY-2017-ES-TRAININGREGISTRY

This webinar will cover the important basic aspects of safe handling and use of compressed gas cylinders. The program will focus on key elements regarding cylinder receiving, transport, storage, and safe handling in the facility and/or laboratory. Federal regulations will be covered, including regulations from DOT, OSHA, and others (NFPA). Cylinder ID requirements, determining hydrostatic test dates and proper shipping on public roads will be addressed.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/WORKING-COMPRESSED-GAS-508282/MAY-2017-ES-TRAININGREGISTRY

This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide which method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/STERILIZATION-PHARMACEUTICAL-PRODUCTS-MD-502502/MAY-2017-ES-TRAININGREGISTRY

Overview: This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.