Role of the Quality Professional in the 21st Century
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Time: 8:30 a.m. - 4:00 p.m.
Perhaps it’s a cliché to say that it is a rapidly changing world. The role of the quality professional in the pharmaceutical industry is changing, or at least it should be changing. The publication of ICH Q10, Pharmaceutical Quality System, in 2009, emphasizes the responsibility of senior management for the quality system. ICH Q10 is one of the most important documents published in recent years for our industry; it is a big step in modernizing our thinking about quality. Along with ICH Q8, Pharmaceutical Development, ICH Q9, Quality Risk Management, ICH Q11, Development and Manufacture of Drug Substances, and the FDA’s Process Validation Guidance (2011), ICH Q10 has revolutionized our thinking about quality, or brought our thinking about quality up to date. ICH Q10 emphasizes the role of top management and the responsibility of senior management for the ownership of the quality system including: its development, implementation, control and improvement. This is, in contrast to the past, emphasis on the quality unit’s responsibility for the quality system . The quality unit still has very important and challenging but different responsibilities.
Today the quality professional makes his or her contribution to the success of the enterprise by improving processes, by promoting quality and by providing a high level of expertise in the use of important quality tools. This requires new learning for many quality professionals. The new, more proactive role, should be more rewarding for the quality professional.
In this course, we will contrast the traditional role of the quality unit with what the modern role of the quality professional should be. We will briefly describe the role of senior management and production management as it relates to the responsibilities of the quality unit. The main emphasis of the course is to provide the participants with an opportunity to learn, mainly through exercises in small groups, some of the recommended new skills. We will discuss process design, evaluation and management, risk and root cause analysis, quality costs and quality metrics, promotion of quality, strategic quality planning, design of a user-friendly documentation system, change management and other skills as time permits.
Who Should Attend
Quality professionals in the pharmaceutical, medical device and related industries, in either a plant environment or in research, will benefit from this course.Prerequisites
The prior reading of ICH Q10, ICH Q9, ISO 9000 is useful. An open mind, desire to contribute and learn are essential.
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Day 1
Upon completion of this course, you will be able to:
- Define a new, more proactive role that makes you more valuable to your organization
- Utilize skills learned in the course that enable you to fulfill this new role
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #267 | ACPE #0116-0000-14-022-L04-P | 1.2 CEUs
Type of Activity: Application
Continuing Education for Professional Engineers
New Jersey
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 12 CPC credits.
North Carolina
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 12 PDHs.
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PDA Training and Research Institute
4350 East-West HighwayBethesda, MD ,
Robert G. Kieffer, PhD
Dr. Kieffer is a recognized authority on quality management and on quality system design, with over 40 years of experience in the pharmaceutical and medical device industries. He combines broad-based business, scientific and technical knowledge with skill as a teacher, facilitator and problem-solver. He has worked in over 50 countries.
Dr. Kieffer is a past president of the PDA, and has worked for Sterling Winthrop Inc. for 19 years. Since 1994, he has been president of his own consulting business. He has numerous publications and presentations to his credit.