What You Get:
- Training Materials
- Live Q&A Session with our Expert
- Participation Certificate
- Access to the 2-day course
In this 2-day course attendees will understand the importance of documentation, writing it down. If you didn’t write it down, it didn’t happen! This is the position of the FDA and most regulatory agencies internationally.
Good documentation is essential for doing business in the GMP world from manufacturing to selling the product.
It is also important for due diligence and regulatory inspections and is necessity for the success of GMP manufactured products and services. While the regulations tell you what you must do, they don’t tell you how.
Based on industry best practices, this course makes it clear how to perfect your existing systems. This course also addresses what documents need to be controlled, what documentation is needed to support your actual system and how to keep your documents current and compliant.
This course provides hands-on methodology and techniques on how to identify systems that require documentary coverage. It also covers the design, implementation and management of such documentation systems to ensure continuous compliance. The course also addresses FDA’s concerns regarding data integrity.
Types of documentation addressed include: quality manuals, policy manuals, standard operating procedures, work instructions, forms, records, etc. The course also addresses aspects of 21 CFR Part 11—Electronic Records and Signatures.
The program consists of lectures, discussions and case studies. Class size is limited to ensure individual interaction with the instructor. Participants are encouraged to discuss their own needs and challenges regarding documentation.
Course 2 Day Agenda
- Implied and explicit regulatory requirements for documentation
- Industry standards
- Management support
- The documents you need to control
- Components of document systems
- System administration
- Document review, approval, and revision
- Document distribution, retrieval, and archiving
- Understanding e-system requirements: validation, security, accountability, and audit trails
- Validation documents
- Standard Operating Procedures and other documents to support the system
- Writing sound procedures
- Consistency in format and terminology
- Training requirements and training documentation
- Remaining “inspection ready”
- Auditing the system
Upon completion of this course attendees will increase their ability to implement efficient practices that meet full GLP/GMP/ICH, ISO, and other regulatory requirements.
Who Will Benefit
This course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries, such as medical device, diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contract organizations. The course will also benefit individuals in a variety of functions such as:
- Product Development
- Clinical Research
Kelly Thomas (25+ year exp.)
Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.