Webinar on 2016 about Monitoring and Enforcing The Quality Agreement

Overview:

Outsourcing and contracting is continuing to increase in the pharmaceutical industry. Regulations have been in place for some time specifying requirements that ensure that appropriate controls are in place.

• This webinar will discuss the history of the regulations with emphasis on changes particularly specific to the Good Manufacturing Practices
• A short overview of the GMP’s quality systems will provide an overall picture of how contracting fits into the pharmaceutical Manufacturing and marketing.
• Pharmaceutical Product Lifecycle will be discussed.
• For each regulation, the citation specific to the topic of contracting/outsourcing will be presented in how it relates to the quality agreement.
• The primary regulatory documents include:
  • ICH Q7A-and Part 210-211
  • ICH-Q8 -Q10
  • FDA Quality Systems Approach
  • FDA Guidance Documents
  • e.-ICH documents, such Part 210-211, and guidance documents) will be explained and how these can be included as required in the quality agreement.
  • Determining the multi-functional team to develop, implement, and maintain quality agreements

This webinar may considerable use of graphics to help explain the concepts

Why should you Attend:

• Obviously, both quality and compliance will be improved. This will reduce the risk of compliance citations and/or “surprises and showstoppers.”
• You will better understand the difference between suppliers and contractors and the requirements for contracting and outsourcing pharmaceutical operations activities, and the related requirements.
• Because contract activities began in R&D and continued throughout the pharmaceutical product lifecycle, to better understand the requirements and how they change as a product reaches commercial development and is released into the marketplace.
• For each of the regulatory requirements for contracts, the individual regulation (i.e.-ICH documents, such as ICH Q7A-Q11, Part 210-211, and guidance documents) will be explained and how these can be included as required in the quality agreement.
• It will help you in the qualification of suppliers and contractors.
• You will learn about the resources and legal and compliance aspects of these agreements and how you will be able to negotiate these contracts with minimal effort.
• It will assist in the planning of new products and/or product improvements.

Who Will Benefit:

• Senior Management-they must learn and understand what’s requirements are all about in order to manage the function
• Supplier & Contractor Quality Personnel
• Purchasing and Finance
• Production
• Shipping and Receiving

Contact Details:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://bit.ly/29nElym
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