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Compliance Training Panel.

Compliance Training Panel provides Quality trainings through their world class platform which enables the clients to discuss with industry experts and to gain related information.

Compliance Training Panel has been established by professionals in the field of Quality, Compliance Auditing and Health Care, Education & Finance with an objective to create an ecosystem that will deliver quality training's on compliance of various regulatory and legal requirements.

We are a US based organization specializing in online trainings in the form of Webinars and Seminars.

Quality Agreements and Annual Inspections
Description :
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 this product. In particular, we will discuss how parties involved in purchasing critical raw materials that 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 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 ?
To avoid 483’s, Warning Letters and a Consent Decree
Areas Covered in the Session :
  • 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 Will Benefit:
  • Quality Departments
  • Quality Control
  • Quality Assurance
  • Regulatory
  • CMO Leadership
  • Production Leadership
About Speaker:
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, Central America, Mexico and Europe. He has worked with or assisted way more than dozens of companies with the establishment of controlled document/quality systems, FDA/EPA 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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