How to Prevent cGMP Violations & Warning letters - Training for Pharma Manufacturing

FDA warning letter and inspection observation trends show a sustained focus on investigating companies for violations of basic GMP requirements and an overall increase in total citations across industry.

To prevent deviations from cGMPs that often result in 483s and warning letters, manufacturing professionals must enhance their manufacturing abilities through continuous education.

ComplianceOnline has engaged exceptional subject matter experts to equip you and your team with well-rounded education in specific pharmaceutical manufacturing areas through the following training bundle. This bundle is suitable for new and seasoned manufacturing professionals who want to learn about cGMP systems to ensure proper design, monitoring, and control of manufacturing processes/facilities.

See what’s covered in the training bundle

Pharmaceutical Manufacturing Process Validation
Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)
Pharmaceutical Manufacturing Equipment Qualification and Maintenance
Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies
Effective Systems for Change Control in the Pharmaceutical Industry
Setting Specifications for Drug Substances and Drug Products
Reviewing Drug Product Batch Records

Pharmaceutical Manufacturing Process Validation

Successful process validation of a cGMP pharmaceutical manufacturing process is essential for obtaining a commercial license. This training will allow your process validation program to be executed quickly and efficiently and will ensure that the process validation you perform supports a successful pre-approval inspection.

Areas Covered in the Webinar:

• Process attributes, parameters and ranges
• Process development, process characterization and process scale-up
• Part 211 requirements
• EMEA and ICH Guidances
• Risk analysis
• Process validation within the overall cGMP validation landscape
• Integrated process validation documentation
• Validation master plans
• Process validation master plans

Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)

This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for APIs, apply these principles in their current roles in order to better manage quality, make improvements, solve problems and make decisions.

Areas Covered in the Webinar:

• ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Applicable portions of the following documents will be discussed as well, in order to define GMPs for APIs during each stage of the product lifecycle per Working Group for ICH Q7:
• ICH Q10 (Pharmaceutical Quality System),
• ICH Q11 (Development and Manufacture of Drug Substances),
• ICH Q8(R2), PART II (Pharmaceutical Development) and
• ICH Q9 (Quality Risk Management)

Pharmaceutical Manufacturing Equipment Qualification and Maintenance

This webinar will provide a risk-based approach from the beginning stages of planning and acquisition of pharmaceutical manufacturing equipment through ongoing usage of the equipment. Planning for and documenting the activities will be discussed.

Areas Covered in the Webinar:

• The importance of risk management for manufacturing equipment
• Validation Master Plans
• Planning for new equipment, commissioning, and completing the design qualification
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Process Validation
• Planning for equipment maintenance
• Documenting equipment maintenance
• The connection with change control
• When to revise your equipment maintenance plan

Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies

This webinar will provide information illustrating that risk-based project delivery and verification processes as currently defined in industry standards and guidance documents are indeed aligned with current US and OUS regulatory expectations.

Areas Covered in the Webinar:

• Process attributes, parameters and ranges
• Process development, process characterization and process scale-up
• Part 211 requirements
• EMEA and ICH Guidances
• Risk analysis
• Process validation within the overall cGMP validation landscape
• Integrated process validation documentation
• Validation master plans
• Process validation master plans

Effective Systems for Change Control in the Pharmaceutical Industry

This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

Areas Covered in the Webinar:

• Purpose of change control
• GMP requirement for change control
• Change control in commercial versus investigational product manufacturing
• Points to consider for change control SOPs
• Levels of change and what is not a “change”
• Considerations for regulatory submissions related to changes
• Annual report
• Changes Being Affected
• Changes Being Effected/30 days
• Prior Approval changes

Setting Specifications for Drug Substances and Drug Products

This training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.

Areas Covered in the Webinar:

• Setting initial specifications
• How to use available data and justify specifications
• ICH specific requirements will be discussed
• Information required to be submitted during the lifecycle
• Updating the specifications during development & commercial phases

Reviewing Drug Product Batch Records

Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.

Areas Covered in the Webinar:

• Regulatory requirements for batch review (EU and US)
• Important areas to check in batch records
• Common errors
• Examples of deficiencies leading to regulatory enforcement action
• Overview of the draft ICH Q12 guidance
• ICH Q12 and Quality by Design
• Benefits of continuous improvement
• Approaches to data trending

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