Building a Compliant Documentation and Training System

Description

This 60 minutes webinar will give a better understanding of the relationship between compliance, documentation, and training. It will provide participants with the ability to effectively meet regulatory requirements, properly integrate training into their quality system, and develop effective compliance documentation that meets both regulatory and training purposes.

There is an increasing trend for regulatory agencies to view compliance documentation and training with increased scrutiny. Documentation and training that is improperly developed, implemented, and/or recorded presents a significant regulatory risk for manufacturers. In addition to meeting regulatory requirements, documentation and training, that is properly developed, also can serve as the basis for a well-controlled operation and a highly-competent workforce.

Areas Covered in the Session :

• Global regulatory requirements for compliance documentation and training
• The relationship between compliance documentation and training
• Read and understand versus demonstrated competence
• Regulatory requirements
• Elements of a compliant documentation and training system
• How to conduct a compliance documentation and training analysis
• Compliance documentation and training as the basis for world-class operational control and performance improvement

Who Will Benefit:

A must attend webinar for all personnel / companies in the Pharmaceuticals, Medical Devices, Biotechnology, Cosmetics, Personal Products, Foods & Beverages fields. The professionals who will benefit include all:

• Training Managers and Directors
• Regulatory Affairs
• Quality Professionals
• Documentation department
• Compliance officer
• Product Development Professionals
• QA/QC analysts
• Internal Auditors
• Quality Assurance scientists
• Production
• Operations
• Consultants
• Quality Unit managers and supervisors

Additional service: (Personalized session)We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.

Personalized session please contact lisa@audiopence.com