Effective Training Practices for FDA Compliance

No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee’s time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors. This seminar will give a good understanding of FDA requirements for training and provide recommendations for implementation.

For easy implementation, attendees will receive

• Primer: Successful compliance training (20 pages)
• SOP: Training for GMP Compliance
• SOP: Training for GxP, 21 CFR Part 11 and Computer Validation

Areas Covered in the Session :

• GxP training requirements in US and EU
• Most frequently cited deviations
• Developing an effective training program for a company, site or department.
• Developing a training plan for individual employees
• Who can or should be responsible for the training program and training plans.
• Most efficient training tools for different tasks.
• Assessment of successful participation
• The benefits of risk based training
• 10 Do’s and Don’ts for permanent success
• Documentation of trainings for the FDA
• Specific training requirements for Part 11

Who Should Attend:

A must attend webinar for professionals in Pharmaceutical development and quality control companies, medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Clinical Research Organizations. The teams that will benefit the most are:

• Training Departments
• Quality Assurance Departments
• Analysts and Lab Managers
• Validation Specialists
• Regulatory Affairs Departments
• Human resources (HR) Departments
• Documentation Departments
• Consultants

Course Director: DR. LUDWIG HUBER

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).