Planning under U.S. FDA CGMP, ICH Q-series and ISO 13485/ 4971 Requirements

Date: Aug 15-16, 2024.

Time: 12 PM ET to 4 PM ET

Duration: 2 day - 8 total hours, 4 hrs./ day.

Level: Intermediate to Advanced

Group Packages: Please contact ben@complyrules.com

Why should you attend -

Verification and validation requirements have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution.

Areas Covered in the Session:

Day 1:

• The Master Validation Plan and it's structure
• Product/ Process / Equipment / Facility Verification / Validation
• Test Cases and Test Report Formats
• When and How to use DQ, IQ, OQ, PQ, or their equivalents
• Product Risk Management (per ISO 14971:2019 and ICH Q9)

Day 2:

• The 11 key documents for software validation
• Incorporating 21 CFR Part 11 requirements
• Data Integrity and Cybersecurity

Who Will Benefit:

• Senior management in Drugs, Devices, Biologics, Dietary Supplements
• QA
• RA
• R&D
• Engineering
• Production
• Operations
• Consultants; others tasked with product, process, software ... validation responsibilities

Target Companies: (Examples)

Abbott, Abvie, Integra, Bard, J&J, Pfizer, GSK, Medtronic etc

Target Association/Societies

AQC, RAPS, AAMI, etc

Target Audience:

• Management
• staff
• operators in Pharma
• Devices,
• Dietary Supplements
• Biologics -- Life Science Industries

Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

• In-Person Seminar going Virtual with increased learner satisfaction.
• Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:
• Our enhanced delivery process and technology provides you with an immersive experience and will allow you to access:
• The real-time and live presentation as in in-person events
• Private chat for company-specific conversation – the same as you would get in an in-person seminar
• Opportunities to connect with your peers to share knowledge at different times and have group discussions
• Live workshop activities
• Live Q&A during the event and offline Q&A assistance after the event
• As usual more content, activities and case studies and now adding homework for a comprehensive understanding

Personalized Training:

The customized training will give you the advantage to do training according to your time and date and the sessions are interactive with a long Q&A session with more in-depth content purely customized for your organization. Want to do a new lab setup, audits, or knowledge on a specific topic. The content of the training will be modified after analyzing your data. We will arrange a call for you and the expert in which you will discuss the areas where your team faces issues and the speaker will design the content accordingly. In addition, personalized sessions give you the opportunity to discuss off-topic issues with our experts.

Includes:

Unlimited participants, Recordings to all the participants with lifetime access, Materials, Certificates, and long Q&A sessions.