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Quality Training for Pharmaceutical and Life Science Disciplines

CfPIE provides technical training courses for companies in the pharmaceutical, biotechnology, and medical device industries.

Email Address
7 Great Valley Parkway,
Suite 295,
Malvern, Pennsylvania 19355,
United States of America
Fax Number

The Center for Professional Innovation & Education (CfPIE) offers the widest range of course options for professional development in the pharmaceutical, medical device, biotechnology, and life sciences industries. We aim to provide content to help individuals and organisations address regulatory concerns in these highly technical disciplines.

CfPIE offers more than 100 customised on-site courses every year at client facilities worldwide. Since 2006, we have trained 34,242 people and served 5,995 companies, government agencies, and non-profit organisations.

Courses for pharmaceutical and biotechnology training

CfPIE’s pharmaceutical and biotechnology courses allow clients to improve day-to-day productivity and enhance long-term career prospects, as well as stay up-to-date on evolving regulations, increasing competition, and advancing scientific discoveries. Our course content is developed and taught by expert, industry-active instructors and is designed to meet scientific, administrative, regulatory compliance, and marketing needs.

Available at every level of experience, CfPIE’s courses minimise potential problems by training lab, clinical, and manufacturing personnel to industry best practices. They can also help companies meet regulatory standards by earning valuable industry certifications.

CfPIE offers comprehensive courses for pharmaceutical, medical device, biotechnology, and life science industry training. Image licensed to CfPIE from LinkedIn Sales Solutions / Unsplash.
Our portfolio includes certification programmes for Good Laboratory Practices (GLP) and other industry standards.
Each of our courses is developed and taught by experts from the relevant industry. Image licensed to CfPIE from Plann /
CfPIE’s on-site training programme enables clients to study our courses from their own offices. Image licensed to CfPIE from Scott Graham / Unsplash.

Pharmaceutical and medical device certification programmes

CfPIE offers comprehensive programmes for a range of pharmaceutical, medical device, and biotechnology industry certifications. These help keep staff informed about industry trends, regulatory changes, and compliance updates, as well as drive motivation, enthusiasm, collaboration and knowledge among team members.

Guided by our experienced course instructors, our certification programmes provide great value for both individuals and their employers. They include the Good Laboratory Practices (GLP) Facility Certification Program and Good Manufacturing Practices (GMP) Facility Compliance Program, both of which are designed to help applicants meet FDA guidelines for good practice.

Custom on-site training for pharmaceutical company staff

CfPIE’s customised on-site training programme gives clients the same in-depth, quality course content from the convenience of their own offices. These courses are ideal whether you are training new hires, preparing for an audit from the FDA or another regulatory body, or updating current personnel on industry or product changes.

Our on-site classes are available for groups of ten or more and offer flexible dates and scheduling options. We also offer our certification programmes in on-site format to increase convenience for our clients.

Analytical method validation for biologics and other therapeutics

CfPIE’s analytical method validation course provides a full overview of the international regulatory authority requirements and expectations for validating pharmaceutical assays. It gives attendees the knowledge and tools needed to plan and execute test method validation packages for the new drug application (NDA), biologics licensing application (BLA), and marketing authorisation application (MAA) market application dossiers.

The course covers in-process, release and stability assays commonly used in quality control (QC) by biologic and biopharmaceutical companies, as well as validation of QC analytical test methods such as electrophoretic, high-performance liquid chromatography (HPLC), and peptide mapping. Also included in the course material are cell-based potency bioassays, immunochemical binding impurity assays, and adventitious agent assays.

Implementing an FDA-compliant stability programme

CfPIE provides training to help companies prepare quality assurance studies for active pharmaceutical ingredients (APIs) and pharmaceutical drug products. These projects typically require stability programme to determine an appropriate and safe stability profile during clinical development, as well as justify a shelf-life for the product to enter the market for FDA regulatory compliance.

The course covers the latest developments in stability testing and the interpretation of stability data. This includes standards for quality by design (QbD), quality risk management (QRM), and pharmaceutical quality systems (PQS), as well as international regulatory guidance from the ICH.

Press Releases

  • OTC Drug and Personal Care Product GMP & FDA Regulation

    Personal care consumer products in the US encompass a broad spectrum of categories, ranging from food/supplements to cosmetics to OTC drug products. They are mainly regulated by the FDA under the Federal Food, Drug and Cosmetic Act (FFD&C Act).

  • Human Error Prevention (HEP) ‒ Risk Factors and Strategies

    Edwards Deming, the famous pioneering leader of Toyota in the mid-1900s, widely regarded as the Father of Modern Quality, said: “85% of the reasons for failure are deficiencies in the systems and process rather than the employee.” Many studies place that number at 95%. This course challenges traditional thinking on what causes, and how to prevent, errors and deviations, and helps transform organisations from looking for people’s errors to finding system flaws and harnessing people for solutions.

  • Ethics in Research ‒ Values for Responsible Conduct of Research

    This 15-hour course addresses ethics and the responsible conduct of research. It goes beyond merely checking the box on compliance training by providing participants with concepts and vocabulary relevant to the ethical challenges expected in any type of research. Participants build skills to identify and address dilemmas that arise in their work.

  • Introduction to Vaccines ‒ CMC Regulatory and Quality Aspects

    This course will introduce the attendee to the historical development of vaccines, the different types (classes) of vaccines in use today, and will orient the attendee to the laws (PHSA, FD&CA) and regulations (ICH, FDA Guidance’s) required for vaccine development and commercialisation. The separate roles of FDA and CDC in the US will be discussed, and the regulatory pathways for marketing authorisation (MAA) of vaccines in the EU will be presented.

  • Change Control ‒ GMP Requirements and FDA Enforcement

    Change Control is arguably the most critical quality system for safeguarding patient safety and product quality. Although specific steps vary from firm to firm, there are a few standard elements and best practices that are essential for a robust, sustainable change control programme. Many firms struggle to complete change controls in a timely manner and spend incalculable time, effort and rework trying to keep up. This course provides a simple, high-level process, along with best practices and techniques, for sticking to it in a timely manner while maintaining compliance and providing safe, effective products for patients.

7 Great Valley Parkway
Suite 295
Malvern, Pennsylvania 19355
United States of America

Email address
Fax Number