Manufacturing Skills

Regulatory expectations are clear about manufactures' responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standards, maintain compliance to regulatory requirements and consistently meet established expectations 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/Establishing-a-Robust-Supplier-Management-Program-505529/NOVEMBER-2018-ES-TRAININGREGISTRY

This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for estimating process capability (e.g. establishing process stability) are discussed first. Distributions are briefly described and methods for estimating ppm levels are presented. 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/Process-Capability-Assessment-for-Normal-and-Non-Normal-Data-503555/NOVEMBER-2018-ES-TRAININGREGISTRY

Overview: Bringing pharmaceutical products to market in China has become much easier for foreign companies. The Chinese FDA (CFDA), now renamed as CNDA, recently made a series of significant changes to the marketing authorisation regulations by issuing a large number of guidelines and opinions (in Chinese).

Overview: Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them. You'll learn techniques that can help you identify hazards and potential harms. You'll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products.

This webinar will cover the OSHA Requirements for Implementing a Noise Conservation Program. This webinar will cover in detail why hearing loss occurs and what can be done to prevent it - both on and off the job. 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/OSHA-Requirements-of-Implementing-a-Noise-Conservation-Program-509358/SEPTEMBER-2018-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. IQ/OQ/PQ validations deliver evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. 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/IQ-OQ-PQ-in-the-Verification-and-Validation-Process-508676/SEPTEMBER-2018-ES-TRAININGREGISTRY

FDA inspections look for noncompliance with applicable manufacturing regulations. During the inspection the FDA investigator makes a "list of observations" that gives examples of violations. The list is known as the "483." Some observations are very serious and can easily lead to receiving a Warning Letter, which threatens legal action. Your response to a 483 plays a critical role in how the agency will evaluate the inspection. A poorly written response or not responding at all will certainly lead to a Warning Letter and follow up action by FDA. 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/Managing-the-FDA-form-483-Inspection-Observations-503502/SEPTEMBER-2018-ES-TRAININGREGISTRY

This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or 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/Mobile-Applications-and-Computer-Systems-Regulated-by-FDA-508531/SEPTEMBER-2018-ES-TRAININGREGISTRY

This FDA audit webinar will highlight the purpose of FDA audits and scope, understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the 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/Regulatory-Inspections-How-to-prepare-for-a-visit-from-an-FDA-auditor-506970/SEPTEMBER-2018-ES-TRAININGREGISTRY

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. 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/Human-Error-Prevention-in-Pharmaceutical-Manufacturing-503932/SEPTEMBER-2018-ES-TRAININGREGISTRY

Overview: In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

This webinar on Service Level Agreements (SLAs) will provide you with sound principles and a set of guidelines for developing and preparing 'effective' Service Level Agreements (SLAs) for an internal service function or an outside service provider.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/Service-Level-Agreements-SLAs-Preparation-Guidelines-for-Effective-SLAs-504427/SEPTEMBER-2018-ES-TRAININGREGISTRY

Brazil is the largest market for medical devices in South America and presents a significant challenge for regulators looking to navigate its complex and dynamic regulatory system. This webinar showcases the regulatory environment and the recent updates from ANVISA in Brazil. 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/Understanding-the-Brazilian-Regulatory-Environment-for-Medical-Devices-508372/SEPTEMBER-2018-ES-TRAININGREGISTRY

The international standard for cleanrooms has undergone a major revision. This webinar discusses the revisions in the context of global GMPs and the overall contamination control strategy. The webinar discusses testing approaches and the assessment of test data. The learning point is with keeping cleanrooms compliant.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/ISO-14644-The-Revised-Standard-and-Implications-for-Cleanrooms-509318/AUGUST-2018-ES-TRAININGREGISTRY

This training on residual solvents will discuss the regulatory landscape for residual solvents and compliance requirements, including interpretation of the majors' sections (classes of solvents, options for describing levels, analytical procedures).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/Residual-Solvents-Take-Advantage-of-the-New-Flexibility-in-Revised-USP-467-507766/AUGUST-2018-ES-TRAININGREGISTRY

Validation of computer systems is a regulatory requirement within the life sciences. "How much to validate" is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks. 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/Effective-and-Practical-use-of-FMEA-For-Risk-Based-Approach-to-Computer-Systems-Validation-503169/AUGUST-2018-ES-TRAININGREGISTRY

Learn how to write SOP and work instructions and explore the true purpose and function of compliance documents. 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/Applying-Global-Standards-to-Life-Sciences-Compliance-Documentation-504874/AUGUST-2018-ES-TRAININGREGISTRY

Learn the complexity, issues and solution for designing and implementing a stability program for large molecule therapeutics. 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/Implementing-a-Stability-Program-for-a-Biologic-508572/AUGUST-2018-ES-TRAININGREGISTRY

This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. 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/Effective-Records-Management-Document-Control-for-Medical-Devices-505756/AUGUST-2018-ES-TRAININGREGISTRY

Understand FDA and ISO training requirements for medical device employee and learn how to manage an effective training process. 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-Employee-Training-Requirements-and-Implementation-Tips-502545/AUGUST-2018-ES-TRAININGREGISTRY