Average Salary for this job is $60,000 as per www.payscale.com/Canada
This unique program is offered over 4 weeks (one full day per week) and classes can be offered on Saturdays based on the students demand. Please contact firstname.lastname@example.org for more information and registration.
This program includes 5 topics:
1- Introduction to Quality Management Systems and Quality Assurance
2- Good Manufacturing Practices (ICH-GMP)
3- Technical and Regulatory writing for QA: (SOP, OOS, Deviation and Validation Reports, Change Control, and Product Quality Review)
4- Audit and Inspection management
5- Handling Product Complaints and Recalls
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.
GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under Title 21 CFR. The regulations use the phrase "current good manufacturing practices" (cGMP) to describe these guidelines. Courts may theoretically hold that a product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards. Since June 2010, a different set of cGMP requirements have applied to all manufacturers ofdietary supplements.
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines, Vietnam and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide", which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials.
GMC is part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorization or product specification.