Quality Systems Training - By Compliance Global Inc

NEW HYDE PARK, N.Y. - Sept. 29, 2015 - PRLog -- Overview

The purpose of this webinar is to provide the topics and basic instructions needed to establish the quality training systems and related practices needed to meet or exceed compliance expectations expected by regulatory agencies (FDA/EPA and ISO) to generate and ensure objective and technically accurate data entry for quality related systems and production operations.

Good Documentation Practices training (GDP) is a term in the pharmaceutical industry to describe standards by which data entry and related documents are created and maintained. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if compliance with GDP is not part of the company’s quality systems performance.

Why Should You Attend

For the same reason the QSIT (Quality Systems Inspector Training) was originated and is now still being used to make sure we “answer all the potential questions” before an inspector comes in to your facility to determine if you are in compliance with the current regulations.

Areas Covered in this Webinar

Multitude of what regulatory agencies are going to review relative to Quality Systems compliance.

• Demonstrate a proactive approach to quality and improve operational efficiency
• Anticipate and meet FDA expectations for a compliant quality system
• Incorporate risk-management plan to quality systems application
• Build a quality-focused culture and facilitate management support for quality systems processes
• Track and organize data efficiently to improve the evaluation process
• Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes
• Integrate risk assessment activities into the product design process to meet expectations of “quality by design
• Identify crucial training issues to address job-specific compliance responsibilities
• Understand the elements of the and how each subsystem is interconnected to the rest in order to meet GMP requirements
• Conduct internal audits to monitor quality and apply corrective actions when appropriate
• Evaluate SOPs, design controls, and validation protocols from a quality perspective and make revisions or improvements as needed
• Organize and manage evaluation data to improve product quality and address customer complaints

Learning Objectives

FDA's findings of the companies Quality System deficiencies fall into a multitude of errors or deficiencies including change control, employee errors, Corrective and Preventive Action (CAPA) and consistent process control as demonstrated through validation and incident tracking systems. The average cost of a Warning Letter remediation effort is estimated at US $750,000 or millions dependent on the product and the identified deficiencies in order to get FDA approval including added resources for consultants, personnel, remediation of legacy records, etc.

The high cost does not necessarily include the ramifications of product recalls or holds, cost of not going into clinical trials or to market with a new product, or delays in FDA 510(k) or PMA (Premarket approval) as a result of a Warning Letter. The cost of FDA non-compliance is therefore WAY more than the cost of compliance which is why Quality Performance is synonymous with PROFITABILITY.

Who Will Benefit

• QA/QC Professionals
• Regulatory Affairs
• Engineering  and Manufacturing
• IT staff
• Suppliers and software vendors

Level

Beginner

For more information, please visit https://www.complianceglobal.us/product/700213

About Compliance Global Inc

Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.

Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.

Email: referrals@complianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515