Process Validation for Medical Device Compliance
(On-site or Virtual Private Group/Company Training)
Location: On-site or Virtual
Who: Your entire company, department, project team, you select
Overview:
Process Validation deficiencies are major quality system (21 CFR Part 820.75) compliance problems found during FDA inspections. Many FDA 483s and Warning Letters cite deficiencies in Process Validation during FDA inspections. A "lack of or inadequate process validation" was the 3rd highest Warning Letter observation right behind Complaint Handling & MDRs (see Complaint, MDR, & CAPA course). Over 349 medical device manufacturers have received Warning Letters that included process validation (21 CFR Part 820.75) deficiencies since 2005. There were 164 FDA-483 Observations in 2017 alone. This course will teach how to comply with FDA process validation regulations so that companies understand what is required to demonstrate compliance. It will also clarify the differences in process validation and various other validation & qualification activities. A logical approach to process validation will be discussed so that compliance is straight forward and easy to understand. Current FDA regulations and international guidance will be discussed. To allow for more time to focus & fully understand the requirements & approach to Process Validation, statistical math details will not be discussed. A former FDA Field Investigator for over 35 years and over 400 QS inspections can be made available as an instructor.What you will learn:
- What is Process Validation and what are FDA and international requirements.
- FDA process validation inspection expectations.
- Unlocking the confusion between Process Validation and Equipment Qualification.
- How to comply with Process Validation requirements & FDA inspections.
- Understanding the benefits and how to implement a Master Validation Plan.
- How to organize & schedule qualification & validation using a Master Validation Plan.
- How software validation relates and integrates with your overall Validation Plan.
- Understand how & when to implement pFMEA (Process Failure Mode Effects Analysis) into Process Validation and Equipment Qualification Processes.
- Using an organized approach unlocks the confusion when changes are proposed.
Benefits of Attending:
- Having an understanding of Process Validation and regulatory requirements of FDA and internationally.
- Understanding the differences of various validation & qualification requirements.
- Being able to create a Process Validation approach at your company.
- Understanding the many benefits of a Master Validation Plan and how to implement a plan.
- Understand how software validation integrates with your overall Validation Plan.
- Understanding how pFMEA is used and how it can be beneficial during the qualification and/or validation process.
Abbreviated Outline:
- A. What is Process Validation
- B. What are FDA and international requirements for Process Validation
- C. Process Validation & Equipment Qualification
- D. Creating a Master Validation Plan
- E. pFMEA-How, what, and when to use
- F. Examples of successful Process Validation activities
- G.Where and how does software validation integrate into the Validation Plan
- H.Real life FDA Warning Letter non-compliant process validation findings...what went wrong
- I. Review & Summary
Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.
Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.
Request a training proposal for your company.