Chapter 6: Project Time Management Information Technology Project Management, Fourth Edition. 2 Learning Objectives ? Understand the importance of project schedules and good project time management. 3Information Technology Project Management, Fourth Edition Learning Objectives ? Use a Gantt chart for planning and tracking schedule information, find the critical path for a project, and describe how critical chain scheduling and the Program Evaluation and Review Technique (PERT) affect schedule development. 4Information Technology Project Management, Fourth Edition Importance of Project Schedules ? Managers often cite delivering projects on time as one of their biggest challenges. 6Information Technology Project Management, Fourth Edition Individual Work Styles and Cultural Differences Cause Schedule Conflicts ? One dimension of the Myers-Briggs Type Indicator focuses on people’s attitudes toward structure and deadline. 7Information Technology Project Management, Fourth Edition Media Snapshot In contrast to the 2002 Salt Lake City Winter Olympic Games (see Chapter 4’s “Media Snapshot”), planning and scheduling was very different for the 2004 Summer Olympic Games held in Athens, Greece. 8Information Technology Project Management, Fourth Edition Project Time Management Processes ? Activity definition: Identifying the specific activities that the project team members and stakeholders must perform to produce the project deliverables.
9Information Technology Project Management, Fourth Edition Activity Definition ? An activity or task is an element of work normally found on the WBS that has an expected duration, a cost, and resource requirements.
10Information Technology Project Management, Fourth Edition Activity Lists and Attributes ? An activity list is a tabulation of activities to be included on a project schedule. 11Information Technology Project Management, Fourth Edition Milestones ? A milestone is a significant event that normally has no duration. 12Information Technology Project Management, Fourth Edition Activity Sequencing ? Involves reviewing activities and determining dependencies.
14Information Technology Project Management, Fourth Edition Network Diagrams ? Network diagrams are the preferred technique for showing activity sequencing. 16Information Technology Project Management, Fourth Edition Arrow Diagramming Method (ADM) ? Also called activity-on-arrow (AOA) network diagram. 17Information Technology Project Management, Fourth Edition Process for Creating AOA Diagrams 1.Find all of the activities that start at node 1. 18Information Technology Project Management, Fourth Edition Precedence Diagramming Method (PDM) ? Activities are represented by boxes.
21Information Technology Project Management, Fourth Edition Activity Resource Estimating ? Before estimating activity durations, you must have a good idea of the quantity and type of resources that will be assigned to each activity.
22Information Technology Project Management, Fourth Edition Activity Duration Estimating ? Duration includes the actual amount of time worked on an activity plus the elapsed time. 23Information Technology Project Management, Fourth Edition Three-Point Estimates ? Instead of providing activity estimates as a discrete number, such as four weeks, it’s often helpful to create a three-point estimate: ? An estimate that includes an optimistic, most likely, and pessimistic estimate, such as three weeks for the optimistic, four weeks for the most likely, and five weeks for the pessimistic estimate. 24Information Technology Project Management, Fourth Edition Schedule Development ? Uses results of the other time management processes to determine the start and end dates of the project. 25Information Technology Project Management, Fourth Edition Gantt Charts ? Gantt charts provide a standard format for displaying project schedule information by listing project activities and their corresponding start and finish dates in a calendar format. 28Information Technology Project Management, Fourth Edition Adding Milestones to Gantt Charts ? Many people like to focus on meeting milestones, especially for large projects. 31Information Technology Project Management, Fourth Edition Critical Path Method (CPM) ? CPM is a network diagramming technique used to predict total project duration. 32Information Technology Project Management, Fourth Edition Calculating the Critical Path ? Develop a good network diagram.
The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities. The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI). The currently valid version of the EU GMP Guide  Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015.
With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances. The European Medicines Agency (EMA) has released a Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice – Manufacture of Sterile Medicinal Products which addresses the need to update Annex 1 of the European GMP Guide.


New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation.
FDA Center for Drug Evaluation and Research (CDER) launched an Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative.
The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5).
The US Food and Drug Administration (FDA) has just released a list of all new and revised draft guidances it plans to release in 2015. The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal on November 8–13, 2014.
Before the end of the year the European Commission has published the “Commission Delegated Regulation (EU) No. The EMA has published the final version of the „Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”.
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA.
Officials of Australia and New Zealand have confirmed the plan to stop the development of the joint regulatory authority ANZTPA. This month representatives of the FDA have met with their cross-agency team from the EMA, the European Commission and GMP experts form European Union Member States in London, in order to make progress on mutual reliance on GMP inspections. ISPE released its Drug Shortages Prevention Plan during the 2014 Annual Meeting in Las Vegas, Nevada.
This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”. On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe.
From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents. The European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials.
The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP). The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances. Last week the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. EU regulators have unveiled a new logo which will appear on the websites of all authorised online pharmacies known to provide authentic medicines. The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).
EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture. The FDA, in partnership with other federal and international agencies, took action last week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain. This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation.
The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014.
The EMA has published the final version of the long awaited Guideline on Process Validation “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” on February 24, 2014.


The FDA has published a Draft Guideline for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics.
The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs.
The CFDA has announced the adoption of the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February 12, 2014. As announced by the Swiss Regulatory Authority Swissmedic, a Memorandum of Understanding in the area of therapeutic products was signed with the Korean Ministry for Food and Drug Safety (MFDS). Shortly after the FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products due to particularly serious GMP deficiencies, health agencies in Europe are evaluating the FDA inspection findings to assess if these deviations from GMP have any implication on medicines on the European market. The Health Ministry of India has constituted a sub-committee to prepare guidelines regulating the transportation of drugs in the country.
Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products.
According to pharmabiz, the government of India is planning a revision of its GMP guidelines – Schedule M – and considers making them on par with the WHO-GMP standards. The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) published the results of their last meeting in Osaka: ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally.
Many articles were written before the opening ceremonies predicting that the facilities would not be ready in time … Many people were pleasantly surprised by the amazing opening ceremonies, beautiful new buildings, and state-of-the-art security and transportation systems in Athens. The list should include: ? The activity name ? An activity identifier or number ? A brief description of the activity ? Activity attributes provide more information about each activity, such as predecessors, successors, logical relationships, leads and lags, resource requirements, constraints, imposed dates, and assumptions related to the activity.
Gantt Chart for Project X Note: In Project 2003 darker bars are red to represent critical tasks. The report was developed during a Member State Meeting on SSFFC in October 2014 in Geneva, Switzerland.
Food and Drug Administration (FDA) has published their yearly list of new and revised draft guidances CDER is planning to publish in 2015. Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions. The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products".
The report has been presented in a revised format, following comments from a stakeholder focus group.
Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems.
Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines. According to the EC this became necessary due to changes in various Annexes of the GMP Guide. FDA and the EMA (European Medicines Agency) announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. The Greeks even made fun of critics by having construction workers pretend to still be working as the ceremonies began. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians.
The regulation was issued on 25 November 2014 in the Official Journal of the European Union and has entered into force on 15 December 2014.
Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. 3.Continue drawing the project network diagram until all activities that have dependencies are included in the diagram. 4.As a rule of thumb, all arrowheads should face toward the right, and no arrows should cross in an AOA network diagram.



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