The Pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals for use as medications. Pharmaceutical companies may deal in generic, brand medications or medical devices. They are subject to a variety of laws such as GMPs and other regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.
Good Manufacturing Practices (GMP) Seminars and Certificate programs are designed to introduce someone who is new to Pharmaceutical GMP regulated environment or someone just needing a refresher in GMPs. It covers current WHO, EU EMA, FDA and Health Canada GMP guidelines.
· We deliver training on variety of topics to audiences such as FDA & Health Canada GMPs. GMP Manufacturing, SOPs, investigations, product complaints, audits, product recall, returned goods, change control and CAPA.
· Familiarize audiences with HPFBI, TPD, DIN,CTD, eCTD, MRA, NDA, NOC, EL, QMS, SISPQ, ISO, History of Quality, SPC, EMA, GLPs, ICH guidelines, GDPs, KPIs, CFR, Pharmacopoeia’s and WHO.
Our Team include consultants and experts who hold roles within the Pharmaceutical Industry and are able to consult and train on Pharmaceutical Industry and GMPs.
A Good Manufacturing Practices (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any Pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff.
· Participants will be tested and receive a certificate after successfully completion of each course.
· Seminars and Certificates are intended both for individuals currently working in the Pharmaceutical Industry and who seek to increase their knowledge, and for individuals interested to gain employment in the Pharmaceutical Industry.
Our Certificate Courses will provide students with knowledge of Regulatory Affairs & Labeling, Nutritional Analysis for both Canadian and US food regulatory requirements such as cGMPs, GMPs, HACCP, SOPs, GLPs. Students will also learn the basic knowledge of food and medicine chemistry, food and chemical analysis, microbiology, food and drug development.
The practical aspects of the courses allows the students to get hands-on knowledge for general methods of chemical, physical, instrumental tests such as HPLC, GC, Wet Chemical Methods, Moisture, Colour, Fat, Ash, Protein, etc. After completing our certificate courses the student will not only have theory but also have practical knowledge.
Upon successful completion of one of our certificate courses, graduates will be prepared to work in Food and Pharmaceutical Manufacturing Companies, Food and Pharmaceutical Distribution Companies, Bio-Pharmaceuticals or Major Healthcare Chains.
We provide resources, consulting and training on Pharmaceutical Industry and regulatory (GMP) compliance. We design, develop, and deliver targeted GMP consultation & raining to various audiences.
Our Team include consultants and experts who hold roles within the Pharmaceutical Industry and are able to consult and train on Pharmaceutical Industry and GMPs.
We aim to give you a competitive advantage by helping you design, build and operate your facilities that will fully comply with Good Manufacturing Practice (GMP) regulations as issued by regulatory agencies such as the US FDA, EU EMA and Health Canada.
Maintain your Regulatory compliance by using our services. We design, develop, and deliver targeted GMP training to audiences ranging from production staff to management. Participants will be tested and receive a certificate at the end of the course.
We provide GMP consulting on regulatory GMP compliance and all elements of QMS.