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MEDVACON offers training in cGMP compliance, project management and will customize a compliance course for your organization.
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.
MEDVACON's cGMP course covers the requirements for establishing strong quality management systems, obtaining appropriate quality raw materials, building robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories within a pharmaceutical production environment. Participant involvement is encouraged through the use of practical exercises, quizzes, and examples from actual companies.
MEDVACON's Project Management Training spans a wide variety of areas and if the specific courses below do not fit your needs MEDVACON can easily customize a program that fits your organizations goals.
A pharmaceutical company identified the need for support in developing their internal project management organization to support ongoing efficient and effective operation of project teams. MEDVACON delivered the Executive Briefing, the Two-Day Project Management Training session on the East and West Coast and conducted several Rapid Project Startups. The client was delighted and has scheduled additional Rapid Project Startups at another of their sites.
During MEDVACON's on-site CSV initiative, the client identified the need for third-party compliance training assistance of operational and administrative personnel; to increase staff awareness of quality assurance and compliance standards in a GMP environment. Subsequent discussions with the quality manager identified a continued goal of the client maintaining a strong GMP-compliant organization training that provided quality, production, maintenance, operational with the opportunity to refresh and expand their knowledge to an in-depth and compliant approach in a GMP manufacturing facility. The training program was an immersive on-site engagement.
Following an onsite third-party audit, MEDVACON partnered with the CMO's Associate Director of Quality to provide additional training to increase awareness of quality assurance and compliance standards:
“As part of the company’s continuing education and commitment to excellence, the CMO has identified a need for Compliance Training of the Quality Team with a continued goal of maintaining a strong GMP-compliant organization via a training course for QA Compliance. This training is intended to provide QA auditors and QA managers with basic auditing knowledge and experience, the opportunity to refresh and expand their knowledge and applied skills using a comprehensive approach in a GMP CMO manufacturing facility.”
“In a fast-paced, multiple-shift, versatile work environment, the overarching goal is to raise the proficiency and efficiency level of QA auditors from passive, by-the-book checking of documentation / documents to an interactive and supportive Quality Department that can quickly evaluate issues or gaps, offer compliance guidance / recommendations/instructions with confidence while focusing on solutions that direct the work activities as needed to achieve work schedules, project tasks and meet business timelines, without compromise on compliance.” Consequently, MEDVACON developed and delivered the onsite two-day Training Program as an immersive engagement at the CMO facility.
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