ComplianceOnline

Annual Current Good Manufacturing Practices (cGMP) Training

Instructor: Shana Dressel
Product ID: 705422
  • 18
  • October 2017
    Wednesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min

Live Online Training
October 18, Wednesday 10:00 AM PST | 01:00 PM EST | Duration: 60 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 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

$349.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD 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

$449.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Why Should You Attend:

Good Manufacturing Practice regulations, which have the force of law, require that manufacturers, processors, and packagers of medicinal products take proactive steps to ensure that their products are safe, pure, and effective. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.

Personnel involved in cGMP must have documented training of current Good Manufacturing Practices (cGMP) training. This webinar will focus on the FDC Act and 21CFR federal regulations as applied to cGMP and provide an overview of the US FDA regulations for compliance.

Areas Covered in the Webinar:

  • What is cGMP and why is it important; Brief history of drug manufacturing
  • Describe the federal regulations applied to cGMP and inspections
  • Discuss: Organization and Personnel, Building and Facilities, Equipment, Production and Process control, Laboratory, Quality, Documentation
  • Review listing of guidelines as apply to cGMP
  • Terms and Definitions

Who Will Benefit:

This webinar will be beneficial for all personnel involved in the manufacturing, packaging, labeling, storage, testing, and distributing of medicinal products in US. Personnel in the following roles can especially benefit from the presentation:

  • Quality and Compliance
  • Manufacturing and Packaging
  • IT
  • Operations
  • R&D
  • Equipment, Facilities and Process Engineering Documentation
Instructor Profile:
Shana Dressel

Shana Dressel
Senior Consultant, The Compliance Edge LLC

Shana Dressel is a highly proficient and accomplished leader in Quality Assurance with over 17 years of experience within FDA regulated industries, clinical development through large scale manufacturing (GXP), including large and small molecule drugs, medical devices, and dietary supplements. Shana is the founder of The Compliance Edge consulting company established in 2006 which partners with industries elite drug and medical device manufacturers, providing guidance in regulatory, quality and compliance situations with extensive experience in all phases of drug/device development and manufacturing.

Shana possesses extensive experience in company leadership, quality management, client interaction, regulatory inspection management, supplier management, and GXP auditing.

Follow us :
Validation, Verification and Transfer of Analytical Methods
Upcoming In-person 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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