Good Manufacturing Practices for Pharma Companies – Comprehensive Course ( 8 Modules)

Good manufacturing practice (GMP) is very much essential for making sure that the products are produced as per the quality standard consistently which cannot be eliminated by testing of the final product but rather helps to minimize the risks during the production. Among commonly occurring risks are unexpected contamination of products, incorrect labels on containers, insufficient or too much active ingredient leading to adverse effects, wrong supplier selection, human error during designs, clean room design etc.

Apart from understanding the risk it is essential to make sure each time the risk are mitigated by following the set of best practices and written down procedures so that nothing is missed. Complianceonline has created this comprehensive training course to help pharma companies understand and train all of their staff all of the GMP best practices at a low cost and at their own pace.

The courseware ( delivered in USBs and can be used unlimited time) consists of modules for GLPs and GMPs comparisons, statistical procedures, supplier management best practices, deviation investigations, annual product reviews, human error deviation management, HVAC GMP environment control, Pharma compressed air and contamination control.

Do not delay any more. Hurry ! Get the whole set at 50% flat discount.

All Modules:

Module 1: Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Module 2: FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
Module 3: Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues
Module 4: HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Module 5: Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
Module 6: How to Conduct Annual Product Reviews to Achieve GMP Compliance
Module 7: Effective Deviation Investigators Under GMP
Module 8: Human Error Reduction in GMP Related Environments

Who Will Benefit:

• Quality Assurance/Quality Control Directors, Managers, and Specialists
• Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
• Purchasing/Materials Management Directors, Managers, and Specialists
• Engineering/Development Directors, Managers, and Specialists
• Document Control Managers and Specialists
• Training directors and managers
• Executive management
• Manufacturing operations directors
• Human factors professionals
• Process improvement/excellence professionals
• Laboratory managers and analysts

Module 1 : Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Areas Covered in the Webinar:

• GLP: Good Laboratory Practice
• GLP is an FDA Regulation Training
• Definition of GLPs
• History of GLPs
• Why was GLP Created?
• Objectives of GLP
• Mission of GLP
• Instrumentation Validation
• Analyst Certification
• Laboratory Certification
• Grounds for Disqualification
• Consequences of Noncompliance
• Reinstatement of a Disqualified Facility

Module 2 : FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

Areas Covered in the Webinar:

• Regulatory requirements for supplier qualification
• Learning “who” are considered to be suppliers
• Responsibilities of manufactures and suppliers
• Best practices for supplier selection, qualification and management
• What are the FDA’s expectations in regards to quality agreements?
• What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
• Knowing how to structure a supplier quality agreement
• Best practices for a good quality agreement
• Supplier audits
• Documentation requirements and audit trails

Module 3 : Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues

Areas Covered in the Webinar:

• FDA requirements for raw material management at GMP facilities
• Common risk management practices
• Vendor selection and validation requirements
• Product specific raw material issues: chemical, biologic and botanical raw materials
• Suggested quality control measures
• FDA’s common findings and possible resolutions
• Trends in FDA inspection of raw material processes
• Regional and multinational raw material providers
• Raw material risk management in the global setting

Module 4 : HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

Areas Covered in the Webinar:

• GMP Compliance of Cleanroom Environment
• Regulatory Cleanroom Classification and Requirements
• HVAC System Components
• Cleanroom Design and Layout
• HEPA Filtration
• Differential Pressure and Air Pressure Balancing Considerations
• Temperature and Humidity Controls
• Cleaning and Disinfection
• Non-Viable Particulate Monitoring Systems
• Microbial Monitoring Systems
• Personnel Gowning and Aseptic Practices in Cleanroom
• HVAC System Validation

Module 5 : Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Areas Covered in the Webinar:

• Compressed Air - Importance of Quality
• Pharmaceutical Compressed Air System Design
• Contamination types, sources, cause and effect - Solid particulate, Water content, Total oil content, Microbial bioburden
• Contamination Prevention
• International GMP Testing Standards - FDA/EU GMP guidelines, USP/EP and ISO air standards.
• Sampling, Testing Methods and Specifications

Module 6 : How to Conduct Annual Product Reviews to Achieve GMP Compliance

Areas Covered in the Webinar:

• Annual Product Review definition
• Discuss how to write APRs
• Outline the requirements for APR reporting as per US and EU
• The comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries
• What needs to be included in the report
• A model of an example Annual Product Review Report
• Review of citations

Module 7 : Effective Deviation Investigators Under GMP

Areas Covered in the Webinar:

• GMP requirement for deviation investigations
• Steps in an effective investigation
• Examples of investigative tools to assist with resolution of deviations
• Common problems and pitfalls in deviation investigation
• The special category of Out of Specification (OOS) investigations
• Writing good investigation reports
• Verifying corrective action and preventing recurrence

Module 8 : Human Error Reduction in GMP Related Environments

Areas Covered in the Webinar:

• Background on human error phenomena
• Importance of human error prevention/reduction
• Training and human error
• Facts about human error
• Human error as the root cause
• What is human error?
• How is human error controlled?
• Common mistakes: memory failures, overconfidence, we believe we are above average, visual detection, vigilance effectiveness
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

Instructors:

Joy McElroy, Principle Consultant, Maynard Consulting Company; With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about more than 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA.
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years’ experience in pharmaceutical quality assurance and manufacturing. In his career, Mr Cowan has held various manager / director positions in quality assurance, QC laboratory, technical services validation, manufacturing, and clinical supply manufacturing and distribution. He has taught courses in microbiology at Seneca College (pharmaceutical technology program) in Toronto, Canada.
David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC; His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.
Ginette Collazo, PH.D, is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. She has also implemented human error reduction programs and technology in many small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.

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