In this FDA validation training understand the techniques that will help you define and implement solid validation plans.
Why Should You Attend:
- Are your validation protocols comprehensive and accurate?
- Do you inspect every step of a planned manufacturing system for proper control?
- Are your SOPs written to reflect the validation requirements?
- Do your batch records properly confirm validation data?
A successful validation system ensures that no items are left open and unresolved. This webinar will teach specific techniques to ensure organizations are in compliance with regulatory guidelines concerning initial and periodic validation. We will focus on standardizing validation plans that are designed and implemented in a consistent manner. Further, you will learn techniques that will help you create solid procedures that are unambiguous and complete. We will also examine applicable warning letters and 483s so that your company doesn’t make the same mistakes as other organizations. By building compliance into every aspect of your validation plans, you can concentrate on getting more quality product out the door.
Areas Covered in the Seminar:
- Understand the basis for complete validation plans.
- Master Planning for Validation.
- Critical Documentation Requirements for Successful Validation.
- Te most likely areas for scrutiny.
- Establishing effective procedures that will pass inspections with ease.
- Defining adequate control measures to ensure compliance.
- Determining proper review techniques for records and reports.
- Rehearsing effectively for regulatory audits.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Manufacturing and operations personnel
- QA managers and personnel
- Quality control personnel
- Facility maintenance and calibration personnel
- Logistics and supply personnel
- Anyemployee involved in regulatory audits
Instructor Profile:
Nick Campbell , has spent his 24-year career working in operations for highly regulated industries, including the last 15 years in the pharmaceutical, medical device, and biotechnology sectors. His skills include a high level of proficiency in process engineering and facility operations. He has been instrumental in numerous regulatory audits including FDA, European Union, and Health Canada . He also developed and taught approximately 25 half-day seminars in Quality Systems topics for the Oregon Bioscience Association.
