The Center for Professional Innovation & Education - Medical Device Training

The Center for Professional Innovation & Education (CfPIE) is the global leader in accredited medical device training. Personnel responsible for compliance, regulatory affairs, R&D, quality assurance/quality control, manufacturing and validation will find relevant, up-to-date instruction from leading industry experts in the smallest class environments available.

CfPIE differs from other medical device training providers in that our course directors are noted experts in their field and all currently work in industry. Secondly, CfPIE offers the smallest class sizes, ensuring that individual needs are addressed. Our philosophy remains that anyone attending a CfPIE course should be afforded the most personal attention possible so they can apply what they have learned immediately.

MEDICAL DEVICE TRAINING ON YOUR TERMS

From discovery through production, CfPIE has the solution you need to keep your firm compliant and advance your career. Whether your concerns are of a regulatory, market or technical nature, CfPIE has the course to satisfy your needs. CfPIE has over 100 medical device training titles and provides over 270 courses annually at our classroom facilities in Malvern, PA, Costa Mesa, CA, Dublin, Ireland and our new site in Berlin, Germany. Additionally, we offer hundreds of customized, on-site training solutions at client locations yearly. Listed below are some of the key disciplines our courses cover:

• Analytical techniques
• CAPA (Corrective and Preventative Action)
• Clinical trials
• cGCP (Good Clinical Practices)
• cGLP (Good Laboratory Practices)
• cGMP (Good Manufacturing Practices)
• Complaint handling
• Computer systems validation
• Effective medical writing
• Failure investigations/process deviation
• FDA and EU regulations
• FDA inspections
• Laboratory safety
• Medical device development
• Medical device submissions: 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
• Microbiology and sterility issues
• Process validation
• QA/QC issues
• Quality System Regulations (QSR)
• Regulatory affairs
• Root cause analysis
• Software development
• Technical writing of regulatory documents
• Writing when English is your second language
• Writing effective Standard Operating Procedures (SOPs)

WHY MEDICAL DEVICE TRAINING IS IMPORTANT

When your firm's systems and products are not compliant, government sanctions and heavy fines are inevitable. CfPIE's faculty of industry experts will help your staff navigate the jungle of confusing regulations. Personnel from R&D to regulatory affairs to manufacturing will achieve a better understanding of how to face daily compliance challenges. From regulatory action through remediation, CfPIE has the courses to keep your firm compliant.

CONVENIENCE IN MEDICAL DEVICE TRAINING

Regardless of your location, CfPIE has a convenient pharmaceutical training solution. With locations in Dublin, Ireland, Malvern, PA, Costa Mesa, CA, and our new location in Berlin, Germany there is always a training option close by. Have the need to train multiple personnel? CfPIE can customize any course and deliver it at your location.

MEDICAL DEVICE CERTIFICATION

CfPIE is pleased to offer six certification programs designed to provide life sciences personnel with the robust training they need to advance their careers. By simply attending CfPIE courses and taking the requisite examinations, you can earn a professional certification in one of the following areas:

• Clinical Compliance Certified Professional (CCCP)
• Current Good Manufacturing Practices (cGMP) Certified Professional (GMPCP)
• Quality System Regulation (QSR) Certified Compliance Professional (QSRCP)
• Current Good Laboratory Practices (cGLP) Certified Compliance Professional (GLPCP)
• Certified Medical Writing Professional (CMWP)
• Certified Process Validation Professional (CPVP)

TRAIN WITH THE LEADER

Come see why CfPIE is the preferred provider of training to most of the top 100 life science firms. Medical device should not be a burden, but rather a scheduled part of employee development that fosters efficiency and profitability. Personnel responsible for compliance, validation, regulatory affairs, GxP's and manufacturing all maintain key functions. Ensure they are best equipped to tackle everyday challenges. Your bottom line will thank you.