Writing and Enforcing Effective Standard Operating Procedures (SOP)
Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With 14 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.
Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.
In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.
This course addresses how to write effective SOPs, and work instructions in support of your company's activities.
- Food and Drug Administration (FDA), the International Organization for Standardization (ISO) requirements for documentation
- Effective written SOPs and work instructions
- Mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
- Assessing and writing to the audience to produce effective written SOPs and work instructions
- How the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
- Reviewing and revising documents Writing patterns and knowing the answers to your questions about the English language
Who Should Attend
- QA and QC Managers
- Quality Engineers
- Validation Managers
- Validation Engineers and Specialist
- Operations Managers
- Regulatory Compliance Managers and Personnel
- Technical Writers
Why Should Attend
You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable SOPs and Work Instructions, and how to revise and refine your own and others' writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues, and specific audiences. You will also learn how to implement good documentation practices within your SOPs.