Training Overview
Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.
Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company… or even worse… for your customer. And P&PC continues to be a leading cause of 483 and warning letter observations from the FDA.
Even more alarming, P&PC failures are a leading cause for complaints, malfunctions, and product recalls. This webinar can help you prevent serious issues such as these. You’ll learn about FDA quality system regulation expectations, and how you can successfully and efficiently establish these into your Quality Management System. Join us to learn the essentials of Production and Process Controls.
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Learning Objectives
- Overview of the Regulations
- FDA Expectations
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
Areas Covered
- Establishing P&PC
- Change Control
- Environmental Control
- Personnel Requirements
- Contamination Control
- Buildings
- Equipment
- Manufacturing Material
- Automated Processes
- Inspection, Measuring, and Test Equipment
- Process Validation
- Linkages to the total product life cycle and risk management
- Process Improvement
Who Will Benefit
- Auditors
- Quality Engineers
- Manufacturing Engineers
- Engineering Managers
- Manufacturing Supervisors
- Manufacturing/ Production /Operations Supervisors, Managers, and Directors
- Plant Managers
- Quality Managers
- Employees new to Medical Device Companies
Susanne Manz
Consultant | Educator | Author
Baltimore City County, Maryland, United States
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.
Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.