ComplianceOnline

Clinical Trials and Good Clinical Practice

Instructor: Meryl Wiernik
Product ID: 701575
Training Level: Basic
  • Duration: 60 Min

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
Last Recorded Date: Feb-2010

Training CD / USB Drive

$450.00
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

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Clinical Trials and GCP session will describe the principles of Good Clinical Practice including drug development process and Specifics of GCP and quality as related to central laboratory work.

Why Should You Attend:
All personnel involved in clinical trials, whether working directly in a clinical environment within the pharmaceutical or biotech community, or serving this community as a service provider, are required to understand the standards regulating this industry, including GCP. GCP regulations were created to ensure both ethical and scientific quality when conducting clinical trials, which are investigations involving human subjects that are required to bring new drugs to market. This webinar will provide an overview and definition of Clinical Research and Clinical Trials, regulatory requirements, and Good Clinical Practices. This course will serve as training material for new entrants into this industry, or as a refresher course to those who have not attended a recent review session.

Areas Covered in the Seminar:

This Session will describe the principles of Good Clinical Practice, including:
  • An overview of the drug development process.
  • Description of the principles of ICH-GCP.
  • Regulatory standards and requirements.
  • A description of all parties involved in the drug development process.
  • Overview of good clinical practices.
  • Construction of a clinical protocol.
  • Correct documentation practices.
  • Specifics of GCP and quality as related to central laboratory work.

Who Will Benefit:

This webinar will provide valuable educational information to all management teams in food service industry.
  • This webinar will provide required training for personnel involved in clinical trials, both within the pharma and biotech industries, as well as service providers supporting those industries.
  • New entrants into the clinical industry require an understanding of the regulations and of GCP, and retraining should occur periodically, often yearly for service providers.

Instructor Profile:
Meryl Wiernik, has 25+ years of experience in the clinical trials industry. She has led global Project Management, Operations, and Quality Assurance teams. At Quest Diagnostics Clinical Trials Meryl was the Global Director, Business Systems Integration, where she was responsible for the design and deployment of globally integrated systems, applications and processes essential for delivery of services to the company’s clients located throughout the pharmaceutical, biotechnology and medical devices industries. Prior to joining Quest, Meryl led Clinical Strategic Sourcing groups for Amgen, and Bristol Myers Squibb, responsible for outsourcing and supplier relationship management.

During her 19 yr tenure at Bristol-Myers Squibb, she was instrumental in the conceptualization, implementation, growth, and marketing of the BMS Clinical Laboratory. Additionally, Meryl has served as a consultant for the laboratory, specimen storage, and clinical logistics industries.

Meryl holds a BS in Biology/Medical Technology from Rutgers University and an MBA from Fairleigh Dickinson University.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

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).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading