Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Using the USP, EP, JP Monograph, USFDA Guide to Inspections of High Purity Water Systems, current FDA views and cGMP requirements, this course will provide a sound regulatory framework to understand common water system myths. A variety of practical system designs will be evaluated for compliance, as well as their advantages and disadvantages. Particular attention will be paid to microbial control, laboratory water, key design philosophies, systems and component sanitization procedures, operation, testing and maintenance of equipment and systems for water generation. Examine methods for proper water quality selection, information on compendial and non-compendial water, fundamentals of basic water chemistry and information on common unit operations (deionization, reverse osmosis and distillation). Pre-treatment systems, detailed guidance for selection of construction materials and operation issues related to pharmaceutical water generation systems will also be discussed.
Data integrity is currently one of the highest cited areas in regulatory observations and a topic of great interest within the industry and for regulatory agencies that are re-evaluating industry guidance and their enforcement strategies. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
The inherent complexity and uncertainty of biotechnology makes developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using USFDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. This course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. Course topics includes a long list of activities required to validate biopharmaceutical processes; a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes, and the regulatory requirements for their validation. In addition to classroom lectures, participants will take part in several interactive exercises, solve group problems, and participate in class discussions to understand the underlying principles behind Process Validation. For this advanced course participants should have a basic understanding of C&Q, validation and basic familiarity with biotechnology manufacturing processes and unit operations.
This interactive course will provide tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program. Through interactive workshops participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8(R2), Q9, and Q10) to the documented verification of pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose. Templates will be developed to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.
This 3-day course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management; common system construction deficiencies; cGMP documentation; how to maintain an "inspection ready" state; frequency of testing and balancing; airflow visualization and air change rate reduction. A thorough review of global cGMP regulations and their common interpretations and how they can apply to your facility. The course also examines the challenges and some accepted HVAC solutions for a variety of facility types, including: Laboratories, Bulk Pharmaceutical Chemicals (BPC), Bulk Biologics, Vaccines, Oral Dosage Forms (solid and liquid), Sterile fill/finish, Medical Devices and Combination Devices.
With the USFDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination, understanding lifecycle management techniques for an effective cleaning validation program is paramount. Course topics include: risk-based approach to cleaning development and verification; risk analysis, control, review and communication ; procedures and evaluation tools including FMEA/FEMCA; master planning; PAT; periodic assessment and monitoring; selection of analytical and sampling methods; determination of residues to be targeted and appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. For mature cleaning validation programs, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation program and documentation will be essential takeaways.
Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Guidance on the transition of an organization’s approach to C&Q to one that incorporates a science and risk-based approach will be discussed including the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements.
This course will provide you with the essential concepts and principles of specification, design, C&Q of equipment and systems used to store and distribute water in pharmaceutical manufacturing. Additional topics include understanding the importance of microbiological control; analyzing the principles behind water system testing and qualification; the impact of water quality requirements (compendial and non-compendial); basic requirements for water distribution system component installation and overall system construction; integrating and streamlining commissioning and validation activities; and identifying alternative system designs and their advantages and disadvantages.