Good Manufacturing Practices Training | GMP Course

Training on current Good Manufacturing practices is necessary to ensure that companies maintain their obligations to producing pure and safe drugs and medical devices. This training is intended to ensure that companies are aware of their obligations working in a field regulated by this guidelines training on current Good Manufacturing practices is necessary to ensure that companies maintain their obligations to producing pure and safe drugs and medical devices. This training is intended to ensure that companies are aware of their obligations working in a field regulated by these guidelines

Why Should You Attend

Current Good Manufacturing Practices (cGMP) are a series of guidelines that are intended to regulate the production of drugs and medical devices to ensure that they are produced in a safe manner. During this training, you will get an understanding of why they were developed, and how they shape the everyday procedures that oversee any given company’s work in this field. The organizational structure necessary for work to be performed under cGMP will be explained. Facilities and the appropriate requirements needed to operate each will be discussed in a broad view. Procedures, their requirements, and their structure will be reviewed to ensure that the work done at your facility will meet cGMP guidelines. Knowing what each person’s responsibilities and duties are will ensure that the right work is done by the right person at the right time. Finally, we will review how all of this work should be documented so that people know what is going on at a given company.

Webinar Takeaway

  • The history of cGMP

  • The rationale of cGMP

  • cGMP systems

  • cGMP facilities

  • cGMP procedures

  • cGMP personnel

  • cGMP documentation 

Can't Make this LIVE Webinar?

Simply select the Recorded option when registering and we will send you the link to view the recorded version.

Who will Benefit

  • Quality Control/Quality Assurance

  • Regulatory Affairs

  • Laboratory staff

  • Manufacturing staff

Industries who can attend

This 60 -minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel and compliance training online.





Faculty Todd Graham

Comments

Post a Comment

Popular posts from this blog

Trends in FDA Compliance and Enforcement for Regulated Computer Systems

Image
  FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements . If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.   This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the sys
Read more

General Data Protection Regulation (GDPR) Compliance Training

  The General Data Protection Regulation (GDPR), introduced by the European Union, took effect on May 25, 2018. This regulation has changed how organizations handle personal data of data subjects, including customers, employees, and prospects. Organizations had to revamp their processes and systems to be compliant with the new stringent data protection standards. The purpose of the GDPR is to create better data protection policies and to hold the organizations that handle personal data more accountable. But the transition isn’t easy. The new processes have to be systemic and self-serving rather than ad hoc, manual, and intrusive. This Compliance Seminar would help organization which is affected by the GDPR. It includes a comprehensive and structured plan to achieve GDPR compliance Why should you attend With the introduction of the GDPR, organizations are under intense scrutiny regarding how they use the personal data of customers, employees, and prospects. Non-compliance can lead to h
Read more

Managing The Audit Function In A Global Company

Image
Simply select the Recorded option when registering and we will send you the link to view the recorded version. Join us for a webinar on April 28 for a discussion of the webinar The audit function can be a priceless resource for a global company provided this function has the breadth and depth of critical thinking skills, experience, and quality systems, risk-management, and regulatory know-how to view audits in their proper context and offer the appropriate inputs as part of a comprehensive program of improvement. Audits by themselves are simple inputs to identify non-conformances and deficiencies.  Complex issues require independent examination and unique problem-solving skills.  Employees and functions with this role typically report to executive management since their recommendations must cross various functional and departmental boundaries. Too often, companies default to habits and procedures and this can result in wrong decisions and, at times, fatal results.    Why S
Read more