Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
Registration Options
Individual Registration
Group Registration
Time: 8:30 a.m. - 4:00 p.m.
This course will provide detailed guidance for application and implementation of quality risk management principles throughout the product lifecycle, with emphasis on quality risk management application during commercial manufacturing, and integrating quality risk management into the pharmaceutical quality system. The course will build on the content and principles of ICH Q9, Quality Risk Management. The application of quality risk management will be discussed from a life-cycle approach, from pharmaceutical development to technology transfer, commercial manufacturing, product discontinuation, and will include materials management and contract services. Case study examples of the application of quality risk management will be given for different types of manufacturing operations such as biotech API manufacturing, drug product manufacturing, packaging and labeling.
Who Should Attend
Managers and supervisors in manufacturing, technology transfer, quality assurance and regulatory affairs will benefit from this course.
Prerequisites
A basic understanding of risk management principles will be helpful to participants in this course.
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Day 1
Upon completion of this course, you will be able to:
- Describe when, where, and how to apply quality risk management throughout the product lifecycle with emphasis on commercial manufacturing
- Plan quality risk management activities
- Execute risk assessments and develop an overall strategy for the use of different risk assessment tools
- Establish a quality risk management policy and implement the essential elements for risk management in your organization
- Apply the principles learned to conduct risk management activities for a variety of product-related and operational decisions in your job
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 #224 | ACPE #0116-0000-14-075-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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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.
Renaissance Washington DC Downtown Hotel
999 9th St NWWashington, DC ,
Jeffrey Hartman, Senior Consultant, Concordia ValSource
Amanda McFarland, Consultant, ValSource
Amanda Bishop McFarland, M.S. is a Quality Risk Management and Microbiology Consultant with Concordia Valsource, LLC. She specializes in the creation and implementation of Risk Management programs and in developing risk-based strategies for use in Quality Systems including Quality Control, Validation, and Change Management. In 2015, Amanda presented at the Institute of Validation Technology’s Quality Risk Management Series and IVT’s Microbiology Week. She has a Bachelors of Science (Entomology) and a Masters of Science in Mycology, both from the University of Florida. Amanda is an active member of the Parenteral Drug Association (PDA) and a faculty member of the PDA’s Quality Risk Management and Risk-Based Qualification of Sterile Drug Product Manufacturing Systems training series.