SOP Writing, Training and Compliance in the Pharmaceutical Industry

• To articulate the regulatory implications of what is written in an SOP
• To learn the parameters of an effective SOP
• To distinguish a well-written SOP from a poorly written one
• To define processes better by effective interaction with the SOP process owner and/or author
• To revise SOPs effectively and avoid unnecessary complications in procedures
• To improve the writing of SOPs for more effective training and reduction of errors
• To integrate the SOP effectively into the training curricula of employees
• To identify different types of training curricula
• To distinguish curricula from modules and individual training items
• To structure curricula to facilitate qualifying employees to perform functions independently
• To evaluate an employee's qualification to perform tasks using position curricula data
• To take advantage of the connection between SOPs and job performance
• To measure retention of SOP content at the training stage
• To use data from training software to drive continuous improvement and stay ahead of deviations

• Pharmaceutical industry, particularly those areas that develop SOPs for the manufacturing or quality monitoring of pharmaceutical products (Product Development, Production Planning, Manufacturing, Quality Assurance), as well as Information Technology (IT)
• Pharmaceutical companies such as Pfizer, Johnson & Johnson and its associated companies (e.g. Janssen, DePuy-Synthes, Ethicon, Vistakon), Abbott, Merck, Bristol-Myers Squibb, Lilly, Novartis, Novo Nordisk, Amgen, Sanofi, AstraZeneca, Glaxo Smith Kline, Mylan, Almac, Hisamitsu, Cardinal Health, Baxter, Roche, Bayer, Boehringer Ingelheim, Takeda, Teva, Amgen, Biogen, AbbVie, Astellas, Daiichi-Sankyo
• Parenteral Drug Association (PDA), GMP Training Educators' Association (GMP TEA), Institute of Packaging Professionals (IoPP), Association for Talent Development (ATD), Association for GMP Excellence (AGXPE)
• This course will be of benefit to anyone who is an owner of a process, responsible for writing or reviewing procedures, and/or managing training in a GMP environment.