Writing and Enforcing Effective Standard Operating Procedures (SOP)
Product ID : JOYM-0011
Level : Intermediate
Duration : 90 Minutes
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia &UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the 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 19 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, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.
Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.
In 2019 she opened her own company, McElroy Training, and Consultancy, LLC which provides consultants for various projects as well as on and off-site training to pharmaceutical and biotech companies throughout the United States.
Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams through implementing 5 simple techniques she has learned and applied through the years.
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 You 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.