cGMP Training
What is cGMP?
Good Manufacturing Practice regulations 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 must understand how and why cGMP applies to their daily activities, including how these requirements should influence the decisions people make while performing their work – the “GMP Mindset”.
MEDVACON offers a wide variety of options to meet your cGMP training needs, including customized courses for targeting your organization’s specific needs and challenges.
- cGMP Basics Training:
- Providing foundational training on the principles and concepts of cGMP regulations.
- Ensuring employees understand the importance of compliance and its impact on product quality.
- Conducting interactive workshops to explain cGMP regulations and industry guidelines.
- Using case studies and real-world examples to illustrate compliance challenges.
- Role-Specific Training:
- Developing training programs tailored to specific job roles and responsibilities.
- Addressing how different roles contribute to maintaining cGMP compliance.
- GMP Documentation & Good Documentation Practices (GDP) Training:
- Teaching employees how to create, review, and maintain cGMP documentation.
- Covering recordkeeping, standard operating procedures (SOPs), and batch records.
- Training on maintaining accurate and complete records in compliance with GDP.
- Emphasizing the importance of data integrity and traceability.
- Validation and Qualification Training:
- Providing training on validation processes and equipment qualification.
- Ensuring personnel understand the importance of validation in maintaining product quality.
- Explaining risk assessment and management processes within cGMP.
- Teaching employees how to identify, assess, and mitigate risks.
- Audit and Inspection Readiness Training:
- Preparing employees for regulatory inspections and audits.
- Teaching them how to respond to inspector questions and requests.
- cGMP for Managers and Leaders:
- Providing leadership teams with an understanding of cGMP principles.
- Explaining their role in fostering a culture of compliance and quality.
MEDVACON’s cGMP webinar 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. Our course goes
beyond simply listing the requirements or references to the regulations.
Participants gain practical insight into the how and why, and they remain
highly engaged through the use of practical exercises, quizzes, and examples
from actual companies.
Example Projects
cGMP/Compliance Training - API Manufacturer
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.
cGMP and Good Documentation Practices Training
Client personnel participate in PQ executions as well as other documentation efforts. To ensure overall project compliance MEDVACON has conducted cGMP and Good Documentation Practices training. Good Documentation Practices, commonly referred to as GDPs, are the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner. MEDVACON trains our participating client personnel in GDPs using various techniques including classroom training as well as written instructions and procedures on how to properly capture cGMP data during protocol executions.
cGMP/Compliance Training - CMO
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.
CFR Part 11 and CSV / SDLC Training – Genomics Laboratory
MEDVACON was engaged by a renowned genomics laboratory to provide computer system validation for several systems, CSV and SDLC policy and procedure development, and training. The client, who was new to the concept of meeting cGMP requirements, requested that MEDVACON provide 21 CFR Part 11, CSV and SDLC training to their Lab and project managers and software development staff. The half-day training was custom tailored to incorporate the newly developed SOPs governing Computer system Validation and System Development Lifecycle (SDLC). The training was well-received by the client staff and instrumental in enhancing their knowledge of CSV and operating within a GMP environment.
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