Manufacturing Skills

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements

Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And design problems can have disastrous results for your customer and for your company.

We will consider the following: The Design Control requirements of the CGMPs, 21 CFR 820.30 The Design History File - documenting Product Design Control and its nine elements The Device Master Record and the Device History Record The EU's Medical Device Directive The "Essential Requirements"; and their documentation The remaining elements of a Technical File / Design Dossier Trends Two attendee projects

Since the implementation of NAFTA, Mexico has become a major market for USA exporters. This course will provide an in-depth explanation of the Mexican importing process, including specific rules and documentation. The webinar will also discuss what impact local government and private resources will have on the exporter's transaction process when it comes to tariff costs in this trading environment.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/MEXIAN-IMPORT-PROCESS-505340/AUGUST-2017-ES-TRAININGREGISTRY

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.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-MEDICAL-DEVICE-BIOLOGICS-INDUSTRY-505657/AUGUST-2017-ES-TRAININGREGISTRY

This webinar will provide valuable guidance to medical device manufacturers on how to establish and justify limit values for cleanliness. There are several techniques that may be used to set these limits, including comparison involving statistics and historical data. Justification techniques include biocompatibility and risk assessment. Regardless of what technique is used, regulatory agencies expect that limit values will be set for residual analysis.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/MEDICAL-DEVICE-CLEANLINESS-506851/AUGUST-2017-ES-TRAININGREGISTRY

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.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/BAD-STANDARD-OPERATING-PROCEDURES-SOPs-506264/AUGUST-2017-ES-TRAININGREGISTRY

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same. In this webinar we look at the common causes of Human Error in GMP manufacturing. We outline an approach to reduce these errors with an objective to offer you an insight into the common causes of Human Error and to provide you with a defined approach to investigating risk influencing factors and root cause, reducing Human Error and sustaining error reduction within your own company.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/REDUCING-HUMAN-ERR0R-GMP-ENVIRONMENTS-503587/AUGUST-2017-ES-TRAININGREGISTRY

In this webinar our speaker Lena Cordie will train on how to carry out a gap analysis against the requirements of ISO 9001:2015 to make the transition smooth and transparent. This exercise will provide your organization with structured assistance to highlight the extent to which existing systems and controls cover the requirements of ISO 9001:2015, or to identify an implementation action plan, where needed.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/ISO-9001-2015-QUALITY-MANAGEMENT-SYSTEM-503857/JULY-2017-ES-TRAININGREGISTRY

This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why cleanrooms are designed the way they are.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/ASEPTIC-TECHNIQUE-CLEANROOM-BEHAVIOR-508276/JULY-2017-ES-TRAININGREGISTRY

Flammable materials are substances that can ignite easily and burn rapidly. They can be common materials that are at the most work sites in gas, liquids or solids. In addition, flammable materials may themselves represent a health hazard. This webinar will cover only the flammable and combustible liquids handling and storage. This webinar will cover OSHA and NFPA standards that govern the handling and storage of these liquids. Currently flammable and combustible liquids are used in the pharmaceutical, chemical and other industries in different part of the process.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/SAFE-WORK-PRACTICES-505171/JULY-2017-ES-TRAININGREGISTRY

The deadline for implementation of the new elemental impurities guidelines for drug products and ingredients is fast approaching. Implementation is scheduled for January 2018, by which manufacturers of pharmaceutical drug products must comply with USP <232>/<233> and ICH Q3D.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/ICH-Q3D-USP-232-233-ELEMENTAL-IMPURITIES-508597/JULY-2017-ES-TRAININGREGISTRY

The interest-charge domestic international sales corporation (IC-DISC) tax incentive for manufacturers, producers, resellers and exporters of exported U.S.-manufactured products offers the opportunity to decrease federal income tax on a portion of exports by 20 percentage points. Now is the time to explore how different structuring opportunities can help an exporter implement an IC-DISC or to maximize its IC-DISC benefit.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/STRUCTURING-IC-DISCs-MAXIMIZE-TAX-BENEFITS-504166/JULY-2017-ES-TRAININGREGISTRY

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