Pharma & Cosmetics courses

Through interactive workshops and audit role play, learn to audit your Cosmetic GMP's, according to ISO 22716:2007 and ISO 19011:2011 guidance.

This 1-Day course is designed through interactive training, for participants to learn to interpret and apply the FDA requirements for production, quality systems, and management of finished pharmaceuticals: 21 CFR 210 and 211. Learners will discuss ways to minimize or eliminate issues related to contamination, mix-ups, superpotency/sub-potency, misbranding, bioavailability, and safety and efficacy.

Through a series of interactive sessions and hands-on workshops, become familiar with the World Health Organization (WHO) Good Distribution Practices (GDP) for Pharmaceutical Products, in order to help you ensure compliance.

The purpose of this course is to equip learners with a general overview and understanding of the requirements of ISO/IEC 17025:2017.

The objective of this course is to provide learners with the knowledge and skills required to perform an internal audit of part of a LMSbased on ISO/IEC 17025:2017 (or equivalent) and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.

Through a series of interactive workshops and discussion, learn to help your organization demonstrate Good Manufacturing Practice (GMP) compliance using ISO 22716:2007.  Strengthen your internal auditing skills and your ability to assess workplace situations.Course Topics:Overview of GMP and ISO 22716ISO 22716 ClausesThe Audit, Reporting, and Follow-UpAudit Role Play: Preparation, Performance, Presentation of Findings and Specimen Exam ReviewWritten ExamLearning Review and Summary 

Through a series of discussion-based sessions and interactive workshops, learn how to help your organization demonstrate Good Manufacturing Practice (GMP) compliance using ISO 22716.  Build a strong foundation of knowledge and skills. Course Topics: Overview of GMP and the Standard  Clause 3 and Personnel Requirements  Clauses 4 and 5: Premises and Equipment Requirements  Clauses 6-11 and Documentation Requirements  Clauses 12-17 and Continual Improvement  Learning Review and Summary

During this interactive training, learn to interpret and apply the FDA requirements for production, quality systems and management of finished pharmaceuticals: 21 CFR 210 and 211.  Discuss ways to minimize or eliminate issues related to contamination, mix-ups, superpotency/subpotency, misbranding,  bio-availability, and safety and efficacy.These regulations apply to ingredients (API's and excipients) and finished dosage forms administered to humans and animals, OTC, Rx products, Biologics, and veterinary drugs.The FDA requires employees, contractors, and consultants supporting FDA cGMP activities to have sufficient education, training, and experience to perform their assigned functions. Annual cGMP training with effectiveness testing improves individual contributor working knowledge, skills, and effectiveness; helps to proactively reduce regulatory risks; and facilitates FDA compliance. Investing in FDA Compliance Training is essential to the qualifications, growth, and success of any individual wanting to support FDA-regulated activities.

In this training, you will interpret the requirements of the good manufacturing practice (GMP) Pharmaceuticals EU Directive for medicinal products for human and veterinary use, and for Medicinal Products and Active Substances used as Starting Materials with its application in the context of EudraLex Volume 4.