- Recent guidance documents
- Industry practices
- Examples of process validation protocols
- What should be included in process validation protocols
- The Importance of good process validation
- Common mistakes in process validation
Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities. In this webinar, the basics of process validation will be explored along with current industry practices. The recent draft FDA Guidance Document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols.
Process Validation is required by FDA and most worldwide regulatory bodies. Process Validation demonstrates consistency of pharmaceutical production processes. Process Validation requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product.
Sue Dill Calloway ,
Patient Safety and Healthcare Consulting and Education
Sue Dill Calloway, R.N., M.S.N, J.D. is a nurse attorney and President of Patient Safety and Healthcare Consulting and Education. She is also the past Chief Learning Officer for the Emergency Medicine Patient Safety Foundation and a board member. She was a director for risk management and patient safety for five years for the Doctors Company. She was the past VP of Legal Services at a community hospital in addition to being the Privacy Officer and the Compliance Officer. She worked for over 8 years as the Director of Risk Management and Health Policy for the Ohio Hospital Association. She was also the immediate past director of hospital patient safety and risk management for The Doctors Insurance Company in Columbus area for five years. She does frequent lectures on legal, patient safety, and risk management issues and writes numerous publications.
Sue has been a medico-legal consultant for over 30 years. She has done many educational programs for nurses, physicians, and other health care providers on topics such as nursing law, ethics and nursing, malpractice prevention, HIPAA medical record confidentiality, emergency department patient safety and risk, EMTALA anti-dumping law, Joint Commission issues, CMS issues, documentation, medication errors, medical errors, documentation, pain management, federal laws for nursing, sentinel events, MRI Safety, Legal Issues in Surgery, patient safety and other similar topics. She is a leading expert in the country on CMS hospital CoPs issues and does over 250 educational programs per year. She was the first one in the country to be a certified professional in CMS. She also teaches the course for the CMS certification program.
- Director of Quality
- Manager of Quality
- Validation Manager
- Validation Engineer
- Validation Director
- Director/Manager of Regulatory
- Quality Engineers
- Production Managers
- Production Supervisors
- Manufacturing Engineers
- Production Engineers
- Design Engineers
- Process Owners