Application of Quality Risk Management to Non-Production Processes in the Pharmaceutical Quality System
Registration Options
Individual Registration
Group Registration
Time: 8:30 a.m. - 4:00 p.m.
Since the publication of ICH Q9, Quality Risk Management, in 2005, there has been much written about its application to the production process, to product development, and to validation. Relatively little has been published about its application to some of the production supporting processes that are an important part of the pharmaceutical quality system. Annex 2 of ICH Q9 discusses the application of quality risk management to some of these supporting processes: change management/change control, quality defects, auditing/inspection, documentation, training, calibration/preventive maintenance and periodic review. In this course, we will present models of various supporting processes that integrate quality risk management into their design. This use of quality risk management should result in more effective and more efficient processes.
The real benefits from quality risk management arise when it is embedded in all processes, routine activities and the culture of the company. It is a way of thinking. We start toward achieving this goal by redesigning our processes and their accompanying procedures to contain risk analysis as a formal and integral part of the process. In the analysis of risk, we will consider severity, the consequences if a failure occurs, and the probability of failure.
Another neglected aspect of quality risk management that will be discussed briefly in the course is biases/errors made in the estimation of severity and especially the probability of a failure. The course will focus on how to recognize these biases and on how to reduce their influence so that more accurate estimations of severity and probability are obtained. Thus, better decisions can be made.
Who Should Attend
Quality and production managers will benefit from taking this course.
Prerequisites
Students should read ICH Q9 before the course.
Event Location
Contact
Program Inquiries
Training Course Inquiries
Registration Customer Care
More information coming soon.
Day 1
Upon completion of this course, you will be able to:
- Design more effective and efficient non-production processes in which risk management is embedded
- Apply risk management to change control; failures, deviations and CAPA; audits; documentation; training; preventive maintenance; and management review
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 #254 | ACPE #0116-0000-15-027-L04-P | 0.6 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 6 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 6 PDHs.
Become a Sponsor
Interested in becoming a sponsor? Learn about opportunities and benefits.
Request InformationBecome an Exhibitor
Interested in becoming an exhibitor? Learn about opportunities and benefits.
Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA Training and Research Institute
4350 East West HighwayBethesda, MD ,
Robert Kieffer, PhD, RGK Consulting
Dr. Kieffer is a recognized authority on quality management and on quality system design, with over 40 years 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, worked for Sterling Winthrop Inc. for 19 years and, since 1994, has been president of his own consulting business. He has numerous publications and presentations to his credit.