This webinar will discuss setting up statistically justified sampling plans for process validation. The discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
All companies in the pharmaceutical and medical device space are required to implement formal and statistically justified sampling plans and acceptance criteria for validation. Many companies do not have dedicated statistics departments, so it is up to the validation or quality engineer to develop sampling plans. This training will be a simple step-by-step method of developing statistically justified sampling plans and acceptance criteria.
This webinar will discuss methods for setting up sampling plans depending on the risk profile of the final product or production step. It will go into using the sampling plan to set statistically justified acceptance criteria for the validation. Also presented will be setting confidence levels and spreading that confidence level out over multiple runs. Setting statistically justified acceptance criteria for test method validation will also be discussed.
from Medical Device and Pharmaceutical Companies
All companies in the pharmaceutical and medical device space are required to implement formal and statistically justified sampling plans and acceptance criteria for validation. Many companies do not have dedicated statistics departments, so it is up to the validation or quality engineer to develop sampling plans. This training will be a simple step-by-step method of developing statistically justified sampling plans and acceptance criteria.
This webinar will discuss methods for setting up sampling plans depending on the risk profile of the final product or production step. It will go into using the sampling plan to set statistically justified acceptance criteria for the validation. Also presented will be setting confidence levels and spreading that confidence level out over multiple runs. Setting statistically justified acceptance criteria for test method validation will also be discussed.
from Medical Device and Pharmaceutical Companies
Alan M Golden
Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.Alan’s quality assurance experience extends from design control, change control, risk …
How to Write Contracts for Procurement Professionals
How to Deal with Employees Who Love to Argue and Debate Eve…
Project Management for administrative professionals
Sunshine Act Reporting - Clarification for Clinical Research
Onboarding Best Practices for 2025: Proven Strategies to Po…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Reprogramming your mind for Corporate Excellence: 4 Steps t…
Terminating Toxicity: Strategies For Leaders To Confidently…
ChatGPT and Project Management: Leveraging AI for Project M…
Uplifting the Credibility of HR: How to Build the Credibili…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
How to Write Effective Audit Observations: The Principles f…
Strategic Interviewing & Selection: Getting the Right Talen…
Onboarding Best Practices for Millennial and All Employees
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Bridging Generational Divides in the Workplace
Emotional Intelligence: Mastering the Emotions of Great Lea…
FDA Audit Best Practices - Do's and Don'ts
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Accounting For Non Accountants : Debit, Credits And Financi…
Successful Strategies for FDA Expedited Pathways for Your D…
Regulation update Q1 2025: New and Proposed Regulations for…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Pay Transparency in Action: Strategies for Building Trust a…
Designing Employee Experiences to Build a Culture of Compli…
Reinvent Your Business with the Power of AI
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …
Developing and Implementing Quality Culture in the Organiza…
Tips and Techniques for Conducting an Effective Fraud Risk …
Break Free from Toxicity: Reclaim Your Power and Peace
Physician Employment Agreements: Problem Areas that can be …
Measure the Effectiveness of Compliance Programs by Engagin…
FDA Regulation of Artificial Intelligence/ Machine Learning
Quality Management Systems and Data Integrity
Implementing an Effective Human Error Reduction Program
Navigating 2025 Employment Laws: What Every Employer Needs …
Cleaning Data without Complex Functions - A Course for Data…
Succession Plan for 2025: It's Not Just for Emergencies - I…
Employers Should Prepare for Immigration Raids in 2025! Thi…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Using High-Performance Coaching for Managers to Address Per…