ONLINE TRAINING 2015 - Quality Systems Training to get a more Experienced Applicable Perspective based on decades of FDA Interactions, Help with Regulations and Industry Improvements. - By Compliance Global Inc.

Website https://complianceglobal.us/product/700213 | Edit Freely

Category quality management system, quality management training, fda approval process, fda regulations, fda establishment registration, fda regulatory affairs, good documentation practices training, risk management strategies, risk management plan, risk management consulting

Deadline: September 30, 2015 | Date: September 30, 2015

Venue/Country: New Hyde Park, U.S.A

Updated: 2015-09-03 20:30:12 (GMT+9)

Call For Papers - CFP

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 detail please click on this below link:

https://complianceglobal.us/product/700213

Email: referralscomplianceglobal.us

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