ASTM 2500: Lessons Learned Through a Decade of Implementation

Instructor: Kelly Thomas
Product ID: 705911
Training Level: Intermediate to Advanced
  • 4
  • February 2019
    Monday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 90 Min
This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.

Live Online Training
February 04, Monday 10:00 AM PST | 01:00 PM EST | Duration: 90 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$399.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Why Should You Attend:

One of the most critical factors in manufacturing pharmaceuticals and medical devices is ensuring that equipment used for production is properly validated. Validation is required to demonstrate that equipment is fit for its intended use.

In recent years, there have been several standards and guidance documents created to discuss best practices for commissioning, qualification, and validation. One of these documents is the ASTM E2500 standard guide. Unfortunately, some of these documents are too vague and lack the details needed to provide adequate guidance and direction to the industry.

With limited guidance and experience, industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the regulatory authority requirements and expectations for a compliant validation program and demonstrates how ASTM 2500 complies with those requirements.

Because of the tremendous effort expended in conducting validation studies, efficiency and documentation will be stressed throughout the discussion.

This course will provide a thorough review of regulatory guidelines on validation. Each element required to have a complete and thorough validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement.

Areas Covered in the Webinar:

  • Regulatory Requirements for a Compliant Validation Program
    • FDA
    • EU
    • ICH Q7
    • ICH Q8: Pharmaceutical Development
    • ICH Q9: Quality Risk Management
    • Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
  • What is ASTM 2500
    • Definition
    • Concept
    • Requirements
    • Differences from traditional validation approach
  • Real World Examples of ASTM 2500 Implementation
    • Lessons Learned

Who Will Benefit:

  • Operations
  • Quality Assurance
  • Quality Engineering
  • Validation
  • Engineering
Instructor Profile:
Kelly Thomas

Kelly Thomas
Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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Seminars by Ex-FDA Officials

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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