Description:

This industry is regulated by the FDA and the EU, who both recommend a written Quality Agreement between parties to ensure compliance.Between the increased use of pharmaceutical outsourcing and recent publicized quality issues and deficiencies with some CMOs, it is necessary to have a form of quality control oversight. This oversight will offer protection from liability as well as ensuring compliance with Good Manufacturing Practices. The FDA is now recommending a written Quality Agreement between parties. This CMO specific agreement is proof of good intent, and can be provided to FDA and EU inspectors.OnlineAudio will help your organization prepare this Quality Agreement, while giving you a deeper understanding of the regulations and requirements the FDA expects you to fulfill with the agreement itself.

Objectives of the Webinar

It is vital to understand the new FDA and EU requirements and how they affect your enterprise, how a good Quality Agreement can help with issues that affect liability and responsibility, and what is NOT covered with the agreement.

This webinar will address many aspects of a good, effective and compliant Quality Agreement.

• Quality Agreements will be analyzed and highlighted with suggested content, taking the new guidelines into consideration.
• FDA and EU regulatory documents will be compared and discussed.
• The most up-to-date FDA requirements are discussed, along with comments from the industry itself regarding the implementation of these requirements.
• Understanding who is named in an effective Quality Agreement and exactly what the agreement covers.
• The individual responsibilities of both the owner and the contract facility
• Good Manufacturing Practices (GMP) responsibilities explained
• Other Quality Agreement topics covered in detail, including documentation, facilities and equipment, change control, and lab controls, and much more.

Who will benefit:

This webinar will benefit all levels of management and staff, including:

• Outsourcing and External Manufacturing
• Quality Control and Auditing
• Regulatory Compliance and Affairs
• Technology Transfer

Description:

Clean rooms need to be absolutely free from contamination, it so happens that many institutions neglect compressed air as a probable cause of clean room and product contamination. This conference aims to give an insight on the different types of contamination sources particularly compressed. We will also focus on the the different ways to prevent your system from being affected.

Why should you attend?

Participants of this webinar will gain working knowledge on contamination prevention, in particular that related to compressed air. The conference will cover the following:

• Descriptive study of pharmaceutical compressed air systems including the individual components. The study includes detailed engineering diagrams. Component functions are also explored and recommendations given on the optimal component types.
• An insight on the four sources of contamination in compressed air, these are:

1. Solid particulate
2. Water content
3. Total oil content
4. Microbial bioburden

• Prevention of contamination by the above mention sources is discussed
• Presentation of all FDA/EU GMP Guidance, USP/EP and ISO air standards.

Areas Covered in the Session:

• The importance of quality Compressed Air
• Pharmaceutical Compressed Air System Design
• Sources of Contamination
• Prevention of Contamination
• International GMP Testing Standards

Who will benefit:

The following departments, personnel and professionals will benefit from participating in this webinar:

• Quality assurance departments
• Environmental monitors
• Microbiology institutions
• Manufacturing
• Validation
• Engineering
• maintenance

Description:

• Environmental regulation of pharmaceutical clean rooms is fundamental to the production of a quality item. The meaning of Environmental regulation and Ecological Monitoring is debated. Control of conditions like microorganisms, temperature, airborne particulate, moisture, differential weight, air velocity, airflow, and workforce is significant to shield the product from pollution.
• Therefore, the plan, approval and continuoussupervision of a clean room HVAC system is important to guarantee the quality and security of the pharmaceutical products.
• Likewise, an appropriate comprehension and testing the surroundings of the clean room in relation to international regulatory principles is critical from a compliance point of view.

Why should you attend ?

• It is vital that a spotless room's HVAC system is completely realized, appropriately designed and accurately approved. In the event that this is achieved, it will give the environmental control that is required to satisfy the regulatory particulate and microorganism levels needed to produce quality pharmaceutical product.
• The first thing this webinar is about is details and explanation of the diverse US and worldwide regulatory prerequisites for different clean room classifications.
• Afterward, the webinar gives a broadoverview of the technicalities of clean room HVAC. This incorporates engineering graphs and schematics. Components of HVAC equipment are definite and also the computerized control systems that are obtainable. The considerations of clean room design are included. Appropriate construction of buildings and blueprint is important to accomplish both ideal productivity of the system and ideal cleaning and purification of the clean room.
• The standards of HEPA filtration are portrayed alongside required cleanroom airflowmodels and how to accomplish them. Legitimate techniques for HEPA filter spill testing is incorporated.
• The webinar then gives worthwhileinformation on differential pressure, rates of flow, air speed and balancing ofair-pressure. Temperature and relative humidity management and conditions are likewisecomprehensive.
• Detailed methodsof cleaning and purification of the surroundings of theclean room are introduced alongside a survey of the best disinfectants that is presentlyobtainable alongside their individual benefits and hindrances.
• The subject of clean room infectionas a result of staff is discussed This involves both gowning procedure and aseptic practices.
• Lastly, a complete set of prerequisites for HVAC system approval is detailed. Current observing of the clean room surroundings is talked about according to schedule, details, and OOS (out-of-spec) activities that might be needed.

Area covered in the session:

• GMP Compliance of Clean Room surroundings
• Clean Room Design and Layout
• Regulatory Clean Room Classification and Requirements
• Temperature and Humidity Controls
• Differential Pressure and Air Pressure Balancing Considerations
• Personnel Gowning and Aseptic Practices in Clean Room
• Cleaning and Disinfection
• HVAC System Validation
• HEPA Filtration
• HVAC System Components

Who will benefit:

This webinar will give significant help to all staff in:

• Quality Assurance
• Validation
• Engineering
• Manufacturing
• Maintenance
• Environmental Monitoring
• Microbiology

Description:

• Sterile filtration is amongst the major basic steps in sterile pharmaceutical production. This is as a result of the filtration procedure that provides sterility certainty in the finished drug items.
• Therefore, the plan, approval and continuous supervision of a sterile filtration system are significant for guaranteeing the quality and security of the pharmaceutical product.
• Appropriate comprehension and testing of the sterile filtration system as indicated by the international regulatory standards is critical for both the approval and progressing monitoring of the system.

Why should you attend?

• It is vital that the sterile filtration process is completely comprehended and appropriately approved for your specific application. The procedure prerequisites and approval needs are different based on the filtration necessity. This webinar will enable you to have a broad comprehension of this essential topic with an emphasis on the diverse kinds of sterilizing filtration accessible and their application to your specific system. For instance, the utilization of sterile filtration to use point compacted air is talked about in detail.
• A study on diverse filtration media is delivered along with the characteristics and features of the structure of every point. of the diverse filtration media is given the development qualities and properties of each point by point. A comprehensive description of a normal pharmaceutical sterile filtration system with its distinct component is given. engineering representations are incorporated. Microbiology and molecule retention components are examined.
• Integrity testing techniques are examined and in addition media criterion. Techniques for the cleansing of the filter are displayed (SIP, autoclave, and so forth.).
• The appropriate approval of sterile filtration is imperative to guarantee that the filter will reproducibly get rid of unwanted components (bioburden) while permitting entry of desirable components (drug item). The working parameters of time, weight and temperature are completely examined and also the filters possible impact on the products (similarity, endotoxin, leachable, fibers, and so on.). Microbial maintenance trial testing is one of the validation necessities.
• Finally, an assemblage of all FDA/EU GMP administrative directions concerning sterile filtration is introduced. In connection with this; the obligations of the filter producer versus the users of filters is broadly examined.

Areas Covered in the Session:

• Endorsement of Sterile Filter Systems
• Microbial Retention Challenge Testing
• Regulatory Requirements
• Sterile filtration - Significance of Quality
• Sterility Assurance of Sterile Filtration
• Sterile Filtration System Design
• Product Compatibility Testing
• Extractable/Leachable Testing
• Discussion of diverse Filtration Media Properties and Retention Mechanisms
• How to sterilize filters
• Integrity Testing

Who will benefit:

the webinar will give beneficial help to all staff in:

• Validation
• Microbiology
• Manufacturing
• Engineering
• Maintenance
• Quality Assurance
• Environmental Monitoring

Description:

• Supervision of an environment focuses on the outcome of the Environmental Control program – the particulate and microbiological nature of the clean room.
• The FDA Policy on Aseptic Processing GMP (2004) declares:
• Aseptic handling, one of the major essential laboratory regulations is the environmental control program. This program gives important information on the nature of the aseptic handling condition for instance when a given batch is being produced and in addition environmental patterns of auxiliary clean territories. Environmental control ought to expeditiously recognize possible ways of pollution, taking into account the execution of improvements before the products get contaminated.
• In this manner, current environmental control of a clean room condition is important to guarantee the quality and security of the pharmaceutical items.
• Likewise, an appropriate comprehension and testing of the clean room environment as indicated by international controlling standards is vital from a compliance point of view.

Why should you attend?

• Firstly, this webinar will clarify the diverse US and international regulatory necessities for the diverse clean room categories and the environmental supervision of clean room conditions.
• Next, the demonstration specifies the advantages, the administrative prerequisites, and the testing necessities for an exhaustive Environmental Control Program.
• A portrayal of Action and Alert Levels takes place alongside a conversation on how these levels are verified for a specific facility. Remedial and Preventive Actions are characterized.
• All the existing air supervision systems for the estimation of non-feasible particulate are completely examined.
• All existing air and surface checking systems for the estimation of microbial pollutants in the clean room are examined in detail.
• The subject of clean room pollutant as a result of personnel is talked about. This incorporates both gowning system and aseptic practices.
• The current supervision practices for the clean room condition are talked about in regards to sampling recurrence, sampling areas, and the examination of activity level excursions.
• Immediately after this a discussion on how environmental supervision information is studied for the release of a product.
• Finally, an extensive view is taken of the present contemplation on the production and study of Environmental Monitoring Data Trend Reports.

Areas Covered in the Session:

• Clean Room Monitoring Practices - Frequency, Locations, and Investigations
• Environmental Monitoring Program
• Environmental Monitoring Data Trend reports
• Action and Alert Levels
• Product Release
• Non-Feasible Particulate Monitoring Systems
• Microbial Monitoring Systems
• Personnel Gowning and Aseptic Practices in Clean Room
• GMP Compliance of Clean Room Environment
• Regulatory Clean Room Organization and Necessities

Who will benefit:

This webinar will give profitable help to all staff in:

• Maintenance
• Microbiology
• Manufacturing
• Validation
• Engineering
• Quality Assurance
• Environmental Monitoring

Description:

• The knowledge and understanding process is the reason for setting up a method to process control and related direction sets in the Batch Record for every basic step of the procedure operation and the total procedure outcomes in light of the statistical database for every batch of that product code. Techniques for procedure regulation and administrator services can be planned to lessen variation, modify variation during manufacturing and lessen every likelihood for operator mistake, and in addition a general mix to control critical process parameters (CPPs) and additionally the fundamental procedure limits which ordinarily change after the underlying approval and also the pattern analysis for every basic stride of the procedure.
• Batch Records are to be arranged to exhibit and give documented proof every component of the procedure has been assessed for possible quality impact with actualized risk remediation and goal (not subjective) proof each progression has been carried out as directed in the Batch Record. The Batch Record Assessed document is to be presented in a way that guarantees each basic component of the procedure has been implemented and archived according to industry benchmarks for GDP.

Background of the Topic:

A definitive objective of Process Validation is to guarantee ceaseless assurance that once the procedure is initially approved (PQ now PPQ) and submitted for FDA/EU endorsement stays in a condition of control by identifying spontaneous departures from the originally proven recommended procedure to meet cGMP prerequisites by making use of the collection and assessment of data about the consistency of the procedure. By implementing a particularly planned monitoring framework and after that as required by regulatory prerequisites that a statistician or individual with sufficient experience in statistical process control to supervise, test and investigate the quality traits of each basic stage of a procedure and furthermore compare batch to batch consistency utilizing the statistical examination utilizing the suitable model.

Why should you attend?

To acquire an up to date comprehension of the new PV Procedures and the assurance of how to do the essential Statistical Monitoring and Data Analysis to ascertain the procedure is consistent and to keep away from circumstances that could cause 483s, Warning Letters and Consent Decrees and additionally acquiring the ability to evade revamp and review costs.

Areas Covered in the Session:

• Process information and comprehension are the reason for building up a method of dealing with procedure control and related guideline sets in the Batch Record for every unit operation and the total procedure.
• Approaches for procedure control and administrator exercises can be intended to lessen input variation, modify input variation during production and the decreased likelihood of operator blunder, and in addition a general mix to control critical process parameters (CPPs).
• Statistical Tracking (database record and plan) alongside Annual Report Generation
• Variation can likewise be recognized by the timely evaluation of protests about shortcomings, out-of-description findings, procedure divergence reports, procedure yield modification, batch records, incoming raw material records, and unfavorable event reports.
• Production line operators and quality division staff ought to be urged to give input on process operation. We suggest that the quality division meet occasionally with production staff to assess information, talk about conceivable patterns or undesirable procedure modification, and organize any correction or follow-up activities by production.
• To comprehend the business procedure adequately, the producer should consider the impacts of scale. Be that as it may, it is not ordinarily important to investigate the whole working range at business scale if assurance can be given by process plan data. Past reliable experience with adequately similar items and procedures can likewise be useful. Likewise, we emphatically prescribe that firms utilize target measures (e.g., statistical measurements) wherever achievable and important to accomplish satisfactory assurance.
• The objective of the third approval stage is persistent assurance that the procedure stays in a condition of control (the approved state) amid commercial production. A framework or frameworks for identifying impromptu takeoffs from the procedure as outlined is fundamental to achieve this objective.
• Observing the CGMP and GDP prerequisites, particularly, the collection and assessment of data and information about the execution of the procedure, will permit discovery of undesired process modification. Assessing the execution of the procedure detects issues and decides if a move must be made to correct, expect, and forestall issues so the procedure stays in charge (§ 211.180(e)).
• A continuous program to gather and examine products and process information that identify with product quality must be set up (§ 211.180(e)). The information gathered ought to incorporate important process patterns and nature of incoming materials or element, in-process material, and finished products. The data must be statistically trended and explored by experienced personnel. The data gathered ought to confirm that the quality features are properly controlled all through the procedure.
• FDA prescribes that an analyst or individual with sufficient training in statistical process control strategies build up the data gathering design and statistical techniques and methodology utilized in measuring and assessing process soundness and process ability
• The old Process Validation or PQ (process qualification) was initially set-up in the pharmaceutical, not biotech or biopharmaceutical, utilizing three shot with all factors being shot at the goal (the focal point of the limits or range values). Whenever biotech and biologics developed to such an expensive part of the business, unpredicted process factors still within limits started to present product fiasco which is the reason the FDA has included the phraseology about "sound science and the general level of product and procedure comprehension and also provable control – i.e. Sound Scientific Rational (SSR).

Who will benefit?

• Engineering
• Manufacturing Operations
• Creation
• QA/QC
• Research and Development
• Sterility Assurance
• Technical Operations and Validation Experts and also FDA examiners and Internal auditors
• Product and Process Development
• Regulatory Affairs