Instructor :
Charles H. Paul

Webinar ID:
3290

Good Manufacturing Practices are procedures, actions, and standards required to ensure that the products produced within the facility are made and compliant according to quality and regulatory requirements.

cGMP refers to Current Good Manufacturing Practices and is specific to the FDA, implying that those requirements change over time and must be kept current as they apply to your operations.

A company that adheres to cGMPs guarantees, for example, that their pharmaceutical products’ identify, strength, quality, and purity are produced under adequately controlled conditions.

Preparation for a GMP inspection is continuous and a process that must be ingrained into the very fabric of the operational procedures of the business. That process includes:

• Designing a facility that is conducive to effective GMP operations
• Compliant with all GMP regulations related to facility
• All critical processes validated
• All critical aspects of the operation proceduralized and documented in compliant standard operating procedures and trained
• Have a specification as to who performs which procedures or aspects of a procedure
• Records are complete and maintained according to good manufacturing practices
• Good hygiene is practiced by all employees
• Facilities and equipment maintained and maintenance documented
• Quality built into the product
• Regular internal audits conducted to maintain your readiness state.

When a company undergoes a GMP inspection, specific, focused areas of the operation are scrutinized to ensure compliance. Good proactive preparation is the best strategy – hope is not a practical approach to inspection preparation.

The best approach to ensure that you are prepared for an audit is to take a process-oriented approach to conduct operations. That process approach addresses the equipment and the technology, the internal production processes, the materials used in the production process, the people interacting with those processes, and your measurement systems.

In this interactive webinar, Charles H. Paul, a regulatory consultant for over 20 years will address these areas and build the foundation for your organization to meet your inspection challenges successfully.

Join now to learn more…

Good Manufacturing Practices are procedures, actions, and standards required to ensure that the products produced within the facility are made and compliant according to quality and regulatory requirements.

cGMP refers to Current Good Manufacturing Practices and is specific to the FDA, implying that those requirements change over time and must be kept current as they apply to your operations.

A company that adheres to cGMPs guarantees, for example, that their pharmaceutical products’ identify, strength, quality, and purity are produced under adequately controlled conditions.

Preparation for a GMP inspection is continuous and a process that must be ingrained into the very fabric of the operational procedures of the business. That process includes:

• Designing a facility that is conducive to effective GMP operations
• Compliant with all GMP regulations related to facility
• All critical processes validated
• All critical aspects of the operation proceduralized and documented in compliant standard operating procedures and trained
• Have a specification as to who performs which procedures or aspects of a procedure
• Records are complete and maintained according to good manufacturing practices
• Good hygiene is practiced by all employees
• Facilities and equipment maintained and maintenance documented
• Quality built into the product
• Regular internal audits conducted to maintain your readiness state.

When a company undergoes a GMP inspection, specific, focused areas of the operation are scrutinized to ensure compliance. Good proactive preparation is the best strategy – hope is not a practical approach to inspection preparation.

The best approach to ensure that you are prepared for an audit is to take a process-oriented approach to conduct operations. That process approach addresses the equipment and the technology, the internal production processes, the materials used in the production process, the people interacting with those processes, and your measurement systems.

In this interactive webinar, Charles H. Paul, a regulatory consultant for over 20 years will address these areas and build the foundation for your organization to meet your inspection challenges successfully.

Join now to learn more…

The costs of not being compliant, not meeting your inspection challenges, and not being inspection ready are significant.

Those costs or consequences include:

• Warning letters, FDA 483s, consent decrees,
• Product recalls, injunctions, and debarments.

Being prepared is about doing the right things right all of the time.

The only way this can occur – doing those things right – is if everyone in the organization knows

• How to apply GMP to what they do every day
• Consistently practices GMP in every aspect of their work
• Management requires strict compliance to those tenants.

Join Now!

The costs of not being compliant, not meeting your inspection challenges, and not being inspection ready are significant.

Those costs or consequences include:

• Warning letters, FDA 483s, consent decrees,
• Product recalls, injunctions, and debarments.

Being prepared is about doing the right things right all of the time.

The only way this can occur – doing those things right – is if everyone in the organization knows

• How to apply GMP to what they do every day
• Consistently practices GMP in every aspect of their work
• Management requires strict compliance to those tenants.

Join Now!

• GMP Overview
• Preparing for a GMP Inspection
• The consequences of not being ready
• The specific areas that are inspected during a GMP inspection – pharmaceuticals and medical devices

• GMP Overview
• Preparing for a GMP Inspection
• The consequences of not being ready
• The specific areas that are inspected during a GMP inspection – pharmaceuticals and medical devices

This webinar applies to the entire life sciences industry – pharmaceuticals, medical devices, and biologics.

This training will benefit position titles that include Associates, Managers, Directors, Vice Presidents, quality assurance associates, and operations personnel. The following positions are more descriptive of those applicable positions:

• Operations Managers & Directors
• Compliance Managers & Directors
• Training Managers & Directors
• Quality Assurance Managers & Directors
• Associates and operations personnel

This webinar applies to the entire life sciences industry – pharmaceuticals, medical devices, and biologics.

This training will benefit position titles that include Associates, Managers, Directors, Vice Presidents, quality assurance associates, and operations personnel. The following positions are more descriptive of those applicable positions:

• Operations Managers & Directors
• Compliance Managers & Directors
• Training Managers & Directors
• Quality Assurance Managers & Directors
• Associates and operations personnel