Perspective s on Proactive Internal Auditing-for Compliance, Quality System Effectiveness and Product & Process Improvement
Compliance Key INC - Certified Regulatory Compliance
Howard Cooper is a Keynote Speaker at Compliance Key Inc. with over 40 years of experience in Pharmaceutical and Medical Device Quality in startup, small, medium, and large businesses and corporations This experience includes all levels of quality and regulatory affairs.
Webinar Id: LSHCPHTC001
10:00 AM PT | 01:00 PM ET
01/11/2018
Duration: 60 mins
Overview
Senior Management has the responsibility to be involved in design and implementation of the quality system and this responsibility continues to include participation in quality activities. The most productive activity of this continued participation is to ensure that periodic internal audits are conducted to the term the effectiveness of the quality system established and that when deficiencies occur, solutions are effectively implemented.
The effectiveness of the well-known financial internal audit has ensured the stability of the company's financial structure. The internal quality and compliance audit cannot only stabilize operations and ensure consistent quality but can also lead to quality and systemic improvements that benefit the Corporation.
The FDA's first venture into requirement for formal internal audits was in the 1978 Good Manufacturing Practices for Medical Devices, the first GMP issued for medical device. This GMP resulted from the1976 Medical Devices Amendments passed by Congress to regulate medical devices. Him. This GMP also initiated a more quality systems approach for achieving quality as opposed to strong compliance approach. At the same time, The Finished Pharmaceutical cGMP Part 210-211 was also promulgated but lacked proactive QS features such as internal audits.
Now, the internal audit is required and expected throughout the FDA industry.
I have been fortunate to have experienced internal audits of the quality system and of product quality early in my career have seen the benefits. This webinar will begin with the required internal but will expand the internal audit to include product, quality, as well as seeking improvements to focus on customer satisfaction with the product or service.
We are fortunate to work in an industry that demands consistent, predictable, and near-perfect performance. Lives may depend upon. Medical technology is rapidly changing and proactive internal auditing is one tool and help us keep pace.
This webinar goes outside the boxes of normal compliance and quality to challenge your thinking beyond the status quo to make the organization better.
This webinar makes use of graphics to increase understanding.
be no surprises if the quality system was properly designed and implemented, then monitored and audited for compliance to procedures. This is a very good situation but being good is not enough. We want and expect more. A proactive internal auditing system will provide this assurance.
The effectiveness of the well-known financial internal audit has ensured the stability of the company's financial structure. The internal quality and compliance audit cannot only stabilize operations and ensure consistent quality but can also lead to quality and systemic improvements that benefit the Corporation.
The FDA's first venture into requirement for formal internal audits was in the 1978 Good Manufacturing Practices for Medical Devices, the first GMP issued for medical device. This GMP resulted from the1976 Medical Devices Amendments passed by Congress to regulate medical devices. Him. This GMP also initiated a more quality systems approach for achieving quality as opposed to strong compliance approach. At the same time, The Finished Pharmaceutical cGMP Part 210-211 was also promulgated but lacked proactive QS features such as internal audits.
Now, the internal audit is required and expected throughout the FDA industry.
I have been fortunate to have experienced internal audits of the quality system and of product quality early in my career have seen the benefits. This webinar will begin with the required internal but will expand the internal audit to include product, quality, as well as seeking improvements to focus on customer satisfaction with the product or service.
We are fortunate to work in an industry that demands consistent, predictable, and near-perfect performance. Lives may depend upon. Medical technology is rapidly changing and proactive internal auditing is one tool and help us keep pace.
This webinar goes outside the boxes of normal compliance and quality to challenge your thinking beyond the status quo to make the organization better.
This webinar makes use of graphics to increase understanding.
be no surprises if the quality system was properly designed and implemented, then monitored and audited for compliance to procedures. This is a very good situation but being good is not enough. We want and expect more. A proactive internal auditing system will provide this assurance.
Why should you attend this webinar?
This webinar provides a broad overview of the internal auditing functions starting with the concept of quality systems and their objectives. The webinar focuses on the role of the internal audit function throughout the product lifecycle. It focuses on the importance of using knowledge to prevent failure and to improve the quality system.
This webinar will make herbal use of graphical methods to explain the auditing quality concepts.
This webinar will make herbal use of graphical methods to explain the auditing quality concepts.
Areas Covered in the Session:
- Management Responsibilities
- Defining and describing the modern quality system and its lifecycle
- What are the objectives of internal auditing?
- Deming & Juran on the Quality Audit
- Peter Drucker on internal audits
- RASCI & The Stakeholders
- Identifying opportunities
- Product Audits
- Defining the audit process and its cycle
- Organizing the quality audit functions
- The audit team and their qualifications
- Auditing Responsibilities
- Auditing for Quality & Auditing for Compliance
- Auditing can be both subjective and objective
- The inter-functional audit team
- Going way beyond the audit checklist
- Categorizing findings-CAPS, remediation, or improvement
- The audit report life cycle
- Internal Auditing trends
- FDA enforcement of internal audit requirements
- Quality Survey
Who can Benefit:
- Middle and Senior Management from all functions involved in establishing and executing corporate strategy and objectives. It is particularly applicable to companies new to the FDA regulated industry.
- Senior quality management will gain insight on how quality systems work and will be able to better understand senior management responsibilities. Provide knowledge that can be used to persuade others concerning quality matters.
- Finance, Sales and Marketing, Operations, Procurement, and Human Resources who have an active or supporting role in Quality.
- Other quality personnel who have the desire and/or potential to advance to quality leadership.
- Medical Device, Pharmaceutical and Biological Manufacturers
- Combination Product Manufacturers
- Contract Manufacturing Companies
- Regulatory Affairs Professionals Society (RAPS)
- Parenteral Drug Association (PDA)
- Society of Quality Assurance (SQA)
- American Society for Quality (ASQ)
- American Association For the Advancement Of Medical Instrumentation (AAAMI)
- international Society of Pharmaceutical Engineers(ISPE)
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