Quality Agreements and Annual Inspections

Duration: 90 Minutes
This webinar will discuss how parties involved in purchasing critical raw materials can generate patient risk and when the contract manufacturing of drugs have to utilize quality agreements to assure drug quality, safety, and efficacy.
Quality Agreements
Instructor: Jerry Dalfors
Product ID: 500967

Make sure our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (cGMP) as well as vendors supplying product specific raw materials unique to the product. Quality agreements are required for the commercial manufacturing of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), as well as finished drug products from a CMO, combination products, and biological drug products. The intent of this webinar is to ensure we gain the proper perspective of the terms related with “manufacturing” which includes processing, packing, holding, labeling operations, testing, and operations of the Quality Unit.

Why Should you Attend
Manufacturing pharmaceutical products or materials may involve many discrete unit operations and activities. The entire process may be conducted by the owner of the drug, or, alternatively, the owner may engage an outside party or parties to complete the entire manufacturing process, or one or more discrete operations, under the contract. In this document, when discussing the roles and responsibilities of the parties to such contractual relationships, we will refer to the party that introduces (or causes the introduction of) a drug into interstate commerce as the Owner of the drug, whether such drug is covered by a marketing application/license or no. In this guidance, outside entities performing manufacturing operations for the product Owner are called Contracted Facilities.

Objectives of the Presentation
  • Defining the who and what of contract manufacturing including vendor suppliers for specific raw materials
  • Establishing responsibilities of critical vendors and CMOs
  • Contract manufacturing and quality management
  • Documenting contract manufacturing arrangements using the quality agreement or agreements
  • Elements of a quality agreement
  • Objective evidence to demonstrate compliance
  • Contract laboratories are contracted facilities subject to CGMP requirements
Who can Benefit
  • Quality Departments - Quality Control and Quality Assurance
  • Regulatory
  • CMO Leadership
  • Production Leadership
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
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