Developing Effective Procedures


September 23rd, 2021

11:00 AM – 12:00 PM EDT

In this webinar you will learn the key attributes to developing effective procedures based on the foundation of Change Management, Document Management, and Risk Management (plus Design Control as appropriate for medical devices).

  • By planning for and creating a foundational structure, you will create a documents that ensure the information is contained in one primary procedure that is then referenced throughout the system.
  • You will learn what is required in the basic structure of the document: purpose, scope, tasks, responsibilities, etc.
  • You will ensure that the correct responsible groups are creating their content based on the same structure for all type of procedures (e.g., QMS Documents including policies, SOPs, the Quality Manual; GMP Documents including SOPs, work instructions, batch documentation).
  • You will hear who should be writing documents and who should not, what should be included in the document, and what should not.
  • You will reduce document proliferation by systemically creating documents, not creating documents based on a reactionary approach.

Takeaway tools

SOP model which can be used as a template

Do’s and Don’ts for creating documents


SPEAKERS

Jeff Hall

Associate Director, Human Performance, CAI


Jeff Hall is an Associate Director in Human Performance services with over 30 years of experience with implementing programs to support the start-up, operation, and maintenance of process systems and equipment. He has over 20 years of experience managing projects of up to $6M and leading groups of people ranging from one to over 25 persons. Jeff has an MBA and is an expert in Project Management. He uses the skills in these two areas to manage project costs and efficiency. He has used this approach to create focused, effective, and efficient organizations and successful project implementation. He is experienced in auditing, developing programs, and leading projects in GMP, GLP, and GCP environments.


Lisa G. Hawkins

Principal Consultant, CAI


Mrs. Hawkins is a Quality and Regulatory Affairs professional with over 30 years of experience across multiple life science platforms including multiple pharmaceutical dosage forms, medical devices, dietary supplements, homeopathics, and cosmetics.  She has served on several industry representative groups to provide feedback to the FDA on proposed regulations and guidances.